|Year : 2016 | Volume
| Issue : 2 | Page : 48-54
Effect of yoga therapy on quality of life and depression in premenopausal nursing students with mastalgia: A randomized controlled trial with 6-month follow-up
Sukanya Raghunath1, Nagarathna Raghuram1, Sandhya Ravi2, Nidhi C Ram1, Amritanshu Ram1
1 Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana University, Bengaluru, Karnataka, India
2 Prameya Wellness Private Limited, Bengaluru, Karnataka, India
|Date of Web Publication||17-Jun-2016|
324, 5th Cross, 1st Block Jayanagar, Bangalore - 560 011, Karnataka
Source of Support: None, Conflict of Interest: None
Clinical trial registration CTRI/2014/08/004911
Introduction: Mastalgia is a common problem and disturbs women's reproductive lives. There is no known organic etiology for mastalgia and also no definitive treatment. Considering the impact of mastalgia on the quality of life (QoL), it appears that mind-body interventions such as yoga would play an important role. Yoga has shown a beneficial effect in reducing pain, anxiety, and depression, thereby improving the QoL. Objective: To compare the benefits of yoga with the physical activity in improving the QoL in nursing students with mastalgia. Materials and Methods: An institutional ethical committee approved this randomized active control trial (RCT) with a follow-up of 6 months on premenopausal women above 18 years with breast pain (pain score >2) of more than 3 months duration. Women already practicing yoga, on hormonal treatment, or diagnosed with malignancy were excluded. Eighty consenting nursing students were randomized into the yoga therapy or control (brisk walk) arm (for 12 weeks). QoL and Beck Depression Inventory (BDI) questionnaires were administered prior to the intervention and 3 months and 6 months after the intervention. Results: RM-ANOVA group effect was significant in BDI, F (1, 67) = 2632.72, P (<0.001) and in overall QoL, F (1, 67) =6881.41, (P < 0.001). Post hoc test (paired sample t-test) showed better improvement in the yoga group (0-3 months, 0-6 months) in both QoL (P < 0.001) (in all the four domains) and depression scores (P < 0.001) compared to the control group. Conclusion: QoL and depression scores improved with yoga in nursing students with mastalgia.
Keywords: Depression, mastalgia, nursing students, quality of life, yoga
|How to cite this article:|
Raghunath S, Raghuram N, Ravi S, Ram NC, Ram A. Effect of yoga therapy on quality of life and depression in premenopausal nursing students with mastalgia: A randomized controlled trial with 6-month follow-up. J Health Res Rev 2016;3:48-54
|How to cite this URL:|
Raghunath S, Raghuram N, Ravi S, Ram NC, Ram A. Effect of yoga therapy on quality of life and depression in premenopausal nursing students with mastalgia: A randomized controlled trial with 6-month follow-up. J Health Res Rev [serial online] 2016 [cited 2020 Jan 26];3:48-54. Available from: http://www.jhrr.org/text.asp?2016/3/2/48/184229
| Introduction|| |
Mastalgia or breast pain is a common problem , with a prevalence of 41-79%. ,, Although the etiology of mastalgia is not clearly understood, several factors including stress, anxiety, and depression , have been a concern. A review of several randomized controlled trials (RCTs) concluded that yoga was better than many control interventions in reducing pain in different parts of the body. ,
Literature says that there has been no research on yoga in mastalgia. Hence, this study was planned to assess the role of yoga therapy on the quality of life (QoL) and depression among subjects with mastalgia through an randomized controlled trial (RCT).
| Materials and methods|| |
Female students between 18 years and 25 years of age, from two residential nursing colleges, namely, IKON College of Nursing in Bidadi and Sri Rajarajeswari College of Nursing in Bengaluru, both in Karnataka in South India were the subjects of the study. All the students lived in the hostel and had come from semi-urban and rural areas of six different states of India (Karnataka, Andhra Pradesh, Tamil Nadu, Maharashtra, and Kashmir) and some parts of Nepal. They all had breast pain (cyclical or acyclical) of more than 3 months.
To ascertain the optimum sample size for the study, effect size values obtained from our pilot study on 10 women with breast pain in the same setting was used. Severity of pain, QoL, anxiety, and depression were measured before and after 12 weeks of yoga therapy practice. Results of seven women who completed the study indicated reduction in pain [effect size (ES) =3.09], anxiety (ES = 1.59) and depression (ES = 2.21), and increase in QoL (ES = 0.80). Using these ES values of QoL powered at 0.95 for two-tailed analysis a sample size of 23/arm was obtained; anticipating an attrition rate of 70% due to the forthcoming academic year, it was planned that 40 subjects would be recruited in each arm.
Inclusion criteria were: Premenopausal women 18 years and above, breast pain more than 3 months requiring reassurance and/or nondrug therapy, breast pain cyclical or acyclical, unilateral or bilateral, with or without fibrocystic disease of the breast, and those who satisfied Cleeland's Breif pain inventory with a pain score of >2. Women with malignancy, postmenopausal women, those with hypothyroidism, those who were on hormonal treatment or oral contraceptive pills, and those already practicing yoga were excluded from the study.
The trial started after the approval from the Institutional Ethical Committee of Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) University (RES/IEC-SVYASA/16/201). The written approval was also obtained from the administrative heads of both the colleges. This study was registered with the Clinical Trial Registry of India (CTRI/2014/08/004911).
After giving an introductory lecture, all the students were asked to give signed informed consent, along with a filled checklist of symptoms, which included questions regarding their breast health, breast pain cyclical or acyclical, history of fibroadenoma, fibrocystic disease, history of breast cancer, age of menarche, menstrual cycle, information about past diagnosis, management, scanning, surgery, other illness, their stress level, happiness scores, diet, shifts in work, lifestyle pattern, along with anthropometric and demographic data.
The Research Medical Officer and a breast surgeon educated the girls about the procedure and the importance of screening in detail to make them comfortable. Along with four female medical officers from the state government, the breast surgeon conducted a detailed physical/clinical examination (breast screening) to look for the features/signs and symptoms. Uniformity was maintained by all the medical officers during the screening. Counseling and educating them with regard to breast care were done during this individual interaction. The screening was conducted in a hygienic environment (biology laboratory of the college) providing them privacy and comfort.
This was a randomized, active control interventional trial wherein 80 participants were randomly divided into two arms. Concealed envelope procedure was performed for randomization. One group underwent yoga therapy and the control arm did brisk walk under supervision for the same duration.
This was an interventional study, and so double blinding was not possible. Computer (www.randomizer.org)-generated random number table was used and the allocation of the subjects was done by the prelabeled sealed envelope method. The research medical officer and four gynecologists, ultrasonologists, and the laboratory team were blind to the groups. The statistician had to be blind as randomization and the final analysis was done by him. The coded answer sheets of the questionnaires were decoded only after completion of the scoring.
The yoga group followed the precise list of practices 75 min daily, 6 days a week for 3 months. During the 1 st month, the yoga sessions were taught by the certified yoga therapist for all the 6 days. After this, the supervised 1-h sessions were given 3 days a week by the therapist and subjects were asked to do self-practice for the other 3 days of the week for the next 2 months. After 3 months, they were asked to practice daily on their own with weekly follow-up classes when the therapist reviewed their diary of daily practice and clarified the queries of both groups. The detailed list of yoga therapy practices is given in [Table 1].
The control group subjects did brisk walk for 1.5 h followed by supine rest for 6 days 1 week under supervision. Lectures were given on breast health, medical concept of a healthy lifestyle, and benefits of diet and exercise. Attendance was taken for both the groups.
Sociodemographic details were obtained with the screening check list. Cleeland's Breif pain inventory and body mass index (BMI) were documented after the clinical examination by the clinician. Ultrasound scanning of the breast to look for fibroadenoma/cysts and blood test to look for hypothyroidism were performed before starting the intervention. Psychological assessments were done by administering QoL and Beck Depression Inventory (BDI) questionnaires before and at 3 months and 6 months after the intervention.
BDI, developed by Dr. Beck in 1961,  aims to evaluate the risk of depression and level of depressive symptoms objectively. The inventory consists of 21 questions, each with four possible answers scored between 0 and 3, with the total score ranging 0-63. The total score demonstrates the level of depression. The score for each item ranges 0-3 and the range of total score is 0-63. A score of 0 ≤ 9: No depression, 10-19: Mild depression, 20-25: Moderate depression, and 26 and above: Severe depression. BDI has been used widely and has Cronbach's alpha coefficient of 0.80 and r 0.74. This instrument has a reliability of 0.48-0.86 and validity of 0.67 with the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for depression. 
BDI questionnaire attempts to measure the intensity, severity, and depth of depression. It is commonly used in a clinical setting as a novel way of diagnosing and categorizing depression in psychiatric settings.
QoL reflects the psychological imbalances that result from amplified responses to incorrectly perceived environmental situations. The World Health Organization quality of life-BREF (WHOQOL-BREF), which is the short version of the WHOQOL-100, is widely used. WHOQOL-BREF consists of 26 items assessing the QoL in four domains (Physical health, Psychological health, Social relationships and Environment) and a general evaluative facet (overall QoL and general health). The psychometric properties of the WHOQOL-BREF is considered good for assessment of QoL in women with benign breast disease.  Higher the scores in WHOQOL-BREF, higher is the QoL. Chronbach's alpha being >0.70.
Data was analyzed using "R" software (ver. 3.1.0). Although the data were not distributed normally, parametric tests were conducted because of the large sample size. The paired and independent t-tests were used to compare within and between group differences. The data for the 6 month follow-up were compared using repeated measures analysis of variance (ANOVA). All tests were two-tailed, with an alpha level of 0.05 and the power maintained at 0.8.
| Results|| |
Detailed participant flow chart is given in [Figure 1].
The recruitment for the trial, data collection, and the baseline to the 3 rd month intervention, along with postdata collection were from October 2013 to February 2014. Six months follow-up was done from March 2014 to August 2014.
All the 80 residential subjects were unmarried [Mean (M) =19.84, standard deviation (SD) =1.15] (range: 18-25 years), the onset of menarche was M = 12.66, SD = 0.97 (range: 11-15 years), the duration of breast pain was M = 13.13, SD = 10.06 (range: 4-60 months), and the BMI was M = 20.61, SD = 3.23. The breast pain score in the pain analog scale was M = 3.67, SD = 1.11 (range: 3-6), a majority of the students, i.e., 58 (72.5%) had cyclical mastalgia while 22 (27%) students had acyclical mastalgia. Practice sessions varied from 56.89 ± 4.29 (out of 72 sessions) in the yoga group and 54.83 ± 4.4 in the control group.
Average scores in QoL were 87.28 ± 6.16 in the yoga group and 86.88 ± 7.07 in the control group. BDI scores were 15.28 ± 6.75 in the yoga group and 14.48 ± 4.67 in the control group. Detailed sociodemographic data, along with psychological variables, are shown in [Table 2].
Results after the intervention
In QoL, comparison of means of the two groups by repeated measures ANOVA showed highly significant between group effect, F (1, 67) =6881.41 (P < 0.001) in overall QoL. The post hoc test (paired sample t-test) showed highly significant improvement at 3 months, t (37) =-9.08, (P <.001) *** and 6 months, t (37) = -7.34, (P <.001) *** in the yoga group as compared to the control group. The detailed results of all the four domains are presented in [Table 3].
In BDI, comparison of means of the two groups by repeated measures ANOVA showed highly significant reduction in depression scores group effect: F (1, 67) =2632.72, P (<0.001). The post hoc test (paired sample t-test) showed significantly better reduction at both 3 months: t (37) =12.96, (P <.001) *** and 6 months: t (37) =8.90, (P <.001) *** in the yoga group as compared to the control group [Table 3]. Degrees of depression before and after intervention in both the groups are presented in [Table 4].
|Table 4: BDI - Number of subjects in different degrees of depression before and after intervention (n yoga - 38; control - 31)|
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| Discussions|| |
The present RCT on 80 nursing students in the age range of 18-25 years with nonorganic breast pain looked at the effect of yoga on QoL and depression in a 6-month period. Results of repeated measures ANOVA showed significant group time interaction (P < 0.001). Post hoc tests revealed significant improvement within the yoga group at the 3 rd month and 6 th month follow-up on all four domains of QoL and BDI [Figure 2] and [Figure 3].
|Figure 2: Bar graph for QoL mean shift from the baseline, intervention at the end of 3 months, and follow-up after 6 months between the yoga group (n = 38) and control group (n = 31)|
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|Figure 3: Bar graph for Beck Depression Inventory (BDI) mean shift from the baseline, intervention at the end of 3 months, and follow-up after 6 months between the yoga group (n = 38) and control group (n = 31)|
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Although some studies point to a negative association of pain and depression with QoL in women with nonorganic mastalgia,  very few interventional studies have measured QoL. Those that did look at QoL after pharmacotherapy did not show a significant change in QoL as many of them were associated with adverse effects.  Looking at nonpharmacological therapies, a pilot study of acupuncture on 37 women with noncyclic breast pain gave four acupuncture sessions over two weeks, with 3 months follow-up showing no significant improvement in any of the domains (mental, physical, emotional, social, or spiritual well-being) of QoL although there was a significant reduction (P < 0.05) in the pain scores by about 67% and pain interference by about 56%.
A randomized pre-post intervention study on 98 (66 experimental and 32 control) Turkish patients with nonorganic mastalgia looked at the effect of a session of psychoeducation on QoL and pain [visual analog scale (VAS)]. While the baseline QOL in both groups was poorer than the normative values for Turkish women, the QoL of those who had psychoeducation was significantly better (SF-36) after 2 months as compared to the control group. 
As there are no published studies on yoga in patients with mastalgia, we have made an attempt to compare the effect of integrated yoga (similar yoga module in a similar setting) with that of other nonorganic pain conditions. In patients with mechanical chronic lower back pain admitted for yoga therapy,  the baseline mean QoL (12 to 13) was much lower in all domains of WHOQOL-BREF than our study (22 to 29) except the social domain in which it was 11.5 in our study. The improvement observed was highly significant in both studies (16-28% in back pain study and 10- 20% in the present study) although the groups were different in their demography (both genders and higher age in the back pain study). A similar work by Deshpande et al. on normal volunteers also looked at the QoL, which showed similar improvements after 3 months intervention on all domains of WHOQOL-100. 
Results of integrated yoga in patients with osteoarthritis of the knee showed about 20-30% increase in (SF36) QoL. 
In the survey on 105 Turkish women with mastalgia with a mean score of 5 on VAS (1-10), 58% were depressive, 30% were anxious, and 4% were depressive and anxious.  Yilmaz, Enver Demirel et al. showed that anxiety, depression, harm avoidance, self-directedness, and self-transcendence scores were significantly higher in premenopausal women with mastalgia in comparison with the age-matched healthy control group of premenopausal women. 
A BDI score [Table 4] less than 9 indicates no depression and that between 10 and 19 indicates mild depression. The mean baseline scores in our sample (around 15) showed that both the groups were in this range of mild depression and the yoga group moved to normal values (<9) at 3 months. In the control group, there were a good number (16) of subjects with reduced depression scores at the 3 rd month who reverted back to depression in the 6 th month although they had the same instructions, monitoring, and counseling by the therapists at regular intervals; the BDI scores in the back pain study also showed similar trends with significant reduction in mean scores moving from mild depression zone (12.13) to no depression zone (6.43). 
The various domains of the WHOQOL-BREF assessed in this study are described below.
The physical health domain deals with features such as mobility, fatigue, pain, sleep, and work capacity. The observed improvement can be attributed to better physical stamina that occurs after maintained stretches followed by deep rest. Other studies on integrated yoga in healthy children and adults have shown better physical stamina.  Better quality and duration of sleep after yoga have been reported in the elderly too. 
In the psychological health domain, the improvement seen deals with questions relating to feelings, self-esteem, spirituality, thinking, learning, memory, etc., may be attributed to a reduction in depression. Yoga is defined as "mastery over the modifications of the mind" (Patañjali),  which is the goal of our integrated yoga program; several studies have shown the effect of yoga in reducing anxiety,  depression,  and stress,  with enhanced mental health as observed by improved perceptual sharpness  and memory. 
Social health domain has questions relating to problems with interpersonal relationships, social support, etc., which could be the main source of stress contributing to mastalgia. In this domain, the baseline scores [Table 3] were lesser than the other three domains in both the groups of students, which improved significantly after the intervention. These were addressed during lectures and at a personal level in yoga counseling sessions. They were aimed at achieving an introspective cognitive change by recognizing the psychological freedom "to react, not to react or change the usual pattern of reaction to situations" highlighted in yoga texts. 
Environmental health domain has questions that deal with problems relating to financial resources, physical safety, and adaptability to physical environment such as pollution, noise, and climate. One of the definitions of yoga (Bhagavad Gîta) says that yoga results in equanimity and balance (samatvam) that can help in better tolerance to environmental changes. 
Studies have shown that yoga changes the physiological responses to stressors by improving autonomic stability with better parasympathetic tone in normal adults. 
There is evidence to suggest that cyclical mastalgia is caused by a latent stress-induced hormonal imbalance as indicated by hyper prolactinemia.  It is observed that patients with cyclic mastalgia and noncyclic mastalgia have increased catecholamine and decreased baseline dopamine level, which suggests that catecholamine may be released due to stress, resulting in altered abnormal sensitivity of the breast tissue.  Yoga may improve the QoL by promoting voluntary reduction in violence and aggressiveness.  Mastery over the emotional reactions of anxiety  or depression  is achieved through restful awareness during all the practices in general and meditation in particular.  Kundalini yoga is found to be beneficial in cases of depression. It stimulates the various autonomic nerve plexus (chakras) and activates pineal organ, which in turn brings homeostasis between sympathetic and parasympathetic activities.  This mastery over emotional surges leads to controlled and need-based physiological responses that may reduce the overtones of hypothalamus-pituitary-adrenal (HPA) axis  during chronic pain. Yoga has an influence on the HPA axis as evidenced by a reduction in cortisol levels in normal  and sick individuals. ,
Hence, it appears that the beneﬁcial effects of yoga in mastalgia could be mediated through HPA axis by stabilizing the HPA axis and promoting autonomic balance. We may hypothesize that yoga helps in restoring the normal biorhythm of reproductive hormones in cases of cyclical or noncyclical mastalgia and thus, improve the QoL .
Strength of the study
To the best of our knowledge, this is the first randomized controlled study (RCT) on the role of yoga therapy in measuring QoL and depression in nursing students with mastalgia. The strengths of this RCT study are adequate sample size, supervised practice sessions, randomization, and the 6 months follow-up with very few dropouts. The uniqueness of the results was the highly significant reduction in depression scores and improved QoL scores. This offers the first evidence to introduce yoga as a noninvasive and cost-effective therapy in treating mastalgia.
Limitations of the study
This study only addressed mastalgia as a solicited symptom. Further study on patients presenting with mastalgia with or without associated fibroadenosis and fibrocystic breast condition will provide an insight into the use and acceptability of yoga as an intervention in a clinical setting.
| Conclusion|| |
This randomized control study of 12 weeks of integrated yoga therapy with 6 months follow-up has shown that nursing students with mastalgia showed a good improvement in QoL and the decreased depression scores than physical therapy exercises for mastalgia.
We are thankful to the Research Officer and the Vice Chancellor, SVYASA, Bengaluru, Karnataka, India for funding and supporting this project. We extend our gratitude to the Principal of the college for permitting us to carry out the trial and the teachers and the staff for assisting us in data collection and supervising both the trial groups. We thank Dr. Judu Ilavarasu for his help in the statistical analysis. We also thank the yoga therapists for giving the sessions. We also extend our heartfelt thanks to all the nursing students for their wholehearted participation in the study.
Financial support and sponsorship
Institutional funding, SVYASA, Bangalore, Karnataka, India.
Conflicts of interest
We do not have any conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]