TITLE: Psycho-Biological Changes with Add on Yoga Nidra in Patients with
Menstrual Disorders: a Randomized Clinical Trial

  ABSTRACT:

Introduction: Menstrual disorders are common
problems among women in the reproductive age group. Yuga interventions may
decrease the physical and psychological problems related to menstrual disorders.
The present study was aimed to assess the effect of Yoga Nidra on psychological
problems in patients with menstrual disorders.   
Methods: A total number of 100 women recruited
from the department of obstetrics and gynecology and were then randomly
allocated into two groups: a) intervention received yogic intervention and
medication for 6 month, and b) control group received no yogic intervention and
they only received prescribed medication). Psychological General Well-Being
Index (PGWBI) and hormonal profile were assessed at the time of before and after
six months on both groups.  
 Results: The mean score of anxiety, depression,
positive well-being, general health, and vitality scores, as well as hormonal
levels, in posttest were significantly different in intervention group as
compared with pretest. But there was no significant difference in control
group.  
Conclusion: Yoga Nidra can be a successful therapy
to overcome the psychiatric morbidity associated with menstrual irregularities.
Therefore, Yogic relaxation training (Yoga Nidra) could be prescribed as an
adjunct to conventional drug therapy for menstrual dysfunction.

BODY.INTRODUCTION:
 Menstrual disorders are common problems faced by women, which contributes to
physical and psychological problems. Most luteal phases marked by menstrual bleed
occurring between 21-35th day with 3-10 days of bleeding and 30-40 ml of
blood loss on an average. Menstrual dysfunction is common problem in the population
of reproductive age group. The affected women have high rates of amenorrhea (9%) and
menstrual irregularity (33%). The psychological factors including stress and
deprivation were found to be associated with menstrual irregularities.1   Approximately 19% of women aged 18-55 years reported experiencing
menstruation-related problems during menstrual cycle throughout their reproductive
life. The problems include fatigue, pain, vomiting, anxiety, and depression.
Fluctuations in hormones that regulate menstruation, such as estrogen and
progesterone, can affect appetite, digestion, and energy levels, which all of which
affect the mood. Therefore, menstrual disorders are common disorders, which
contributes to physical and psychological problems. Either single or combinations of
medications are available for the patients with menstrual disorders, e.g. medroxy
progesterone, norethistrone, ethinyl estrodiol, levonorgestrol, tranexemic acid, and
ethamsylate. Todays, non-pharmacological and complementary approach is proposed for
treatment of these complications.   Practice of Yoga is simplest method of relaxation which helps to improve the
physical and psychological status. Previous study shows that there was significant
alteration of autonomic functions and psychological status by using yoga.   Moreover, regular practice of yoga has positive effects on menstrual cycle and
psychological well-being probably by balancing neuro-endocrinal axis.2 Another study proposed that, yoga
reduced the severity and duration of primary dysmenorrhea. Author also suggests that
yoga is a safe and simple approach for primary dysmenorrhea.3 The significant effect of relaxation
technique was also observed in subjects of premenstrual syndrome, in which the
stress is considerably reduced by relaxation.4,5 Previous studies
also reports the significant effects of the yoga (especially Yoga Nidra) on the
menstrual disorders.6-10   Practice of Yoga Nidra is a simple method of relaxation which is practiced in the
flat lying position of shavasana (lying on the back, the arms and legs are spread at
about 45 degrees), and followings the spoken instruction of yoga therapist. Yoga
Nidra, which is derived from the tantras, is a powerful and wonderful technique.
This technique is not only useful for physical or mental relaxation but also for
preparing the mind for yogic discipline.5It concerns mainly with Pratyahara (the fifth state of Astanga
Yoga which involves withdrawal of senses) and Dharana (concentration). It is to be
understood that ordinary sleep is not relaxation and tensions cannot always be
resolved completely in ordinary sleep. Yoga Nidra is qualitatively different
relaxation. During the practice of Yoga Nidra the consciousness is at different
levels. It is a 'sleep' where all the burdens are thrown off to attain more blissful
state of awareness, a relaxation much more intense than ordinary sleep. When one
practices Yoga Nidra, it opens the deeper phases of the mind.11   Regular and proper practice of Asanas and Pranayamas have been proposed beneficial
for all women. It may be useful for women who suffer from menstrual disorders.
Asanas can be defined as a physical Yoga posture or position that is designed to
help the body and enhance the body's functions. Yoga exercises is useful method by
creating strength and endurance, improving circulation and energy flow, cleansing
organs and other systems, and expanding muscles and joints.   Pranayama is a Sanskrit (ancient Indian language) word meaning "extension of the
prana or breath" or "extension of the life force". The word is composed from two
Sanskrit words: prana meaning life force (noted particularly as the breath), and
ayama, to extend or draw out. (Not "restrain, or control" as is often translated
from yam instead of ayama). Therefore, Asanas and Pranayamas are helpful in
preserving the general health and reducing the minor complaints regarding
menstruation by improving the vigor and strength of the body.12However, it should be noted that,
yogic practices are not advisable during menstruation for 3-5 days.   Yoga helps correcting and balancing the functioning of the endocrine system, toning
up nervous system by relaxing the body and mind, and reducing psychological problems
of the patients.11 In the present
study we want to examine the effect of Yoga Nidra on the menstrual disorders and
psychological problem associated with menstruation.

BODY.MATERIALS AND METHODS:
 The study was a randomized controlled trial among women with menstrual
irregularities. The study was conducted in Lucknw, Uttar Pradesh (India) from 2008
to 2013. The study was granted by institutional ethics committee and written
informed consent was obtained from all participants. Sample size of the study was
calculated with the help of PS Power and Sample Size Calculations (version 2.1.30;
William D. Dupont and Walton D. Plummer, Vanderbilt University, USA), by considering
type I error of 0.05 and power of 80%, the expected difference in the experimental
and control mean was 1.8 with standard deviation of 4.35 and ratio between
intervention and control group was considered.13 A total of 100 subjects were included and were randomly
assigned into two groups including intervention and control group. The intervention
group consisted of 50 subjects who received both Yoga Nidra apart from regular
medications and the control group consisted of 50 subjects who received only
medications.   Subjects were randomly assigned to each group. For this, we used computer-generated
randomization table in the study. Small paper chits written either case or control
were placed in opaque, sequentially numbered envelopes prepared by a biostatistician
who was blind to the participants.   Women suffering from menstrual irregularities diagnosed by senior consultants were
recruited from the Department of Obstetrics and Gynecology, King George's Medical
University U.P Lucknow. Participants aged between 18 to 45 years with current
menstrual irregularities (pathological amenorrhea, dysmenorrhoea, oligomenorrhoea,
polymenorrhoea, hypomenorrhoea, menorrhagia, and metrorrhagia) for more than 6
months were included. Interested individuals were initially screened for eligibility
by senior consultants. According to inclusion and exclusion criteria, eligible
subjects were invited for yoga classes.   Conservatively diagnosed patients who are consenting were recruited. Women having
known gynecological neoplasm, requiring surgery, having Pelvic inflammatory disease
(PID), and pregnant women are excluded from the study.   The anthropometric measurements and history of pervious treatments such as physical
therapy and yoga therapy were inquired and recorded. Either single or combination of
medications e.g. Medroxy progesterone, norethistrone, ethinyl estrodiol,
levonorgestrol, tranexemic acid, ethamsylate were prescribed to the patients by the
consultants as and when required.   Baseline assessments of all the subjects were carried out. Psychological assessment
employing Psychological General Well-being Index (PGWBI) and biochemical parameters
including thyroid-stimulating hormone (TSH), follicle stimulating hormone (FSH),
luteinizing hormone (LH), prolactin, progesterone, estradiol, testosterone, and
DHEA-S (dehydroepiandrostone sulfate) was conducted before and after six months of
Yoga Nidra intervention. Psychological General Well-being Index (PGWBI)14 consists of 22 self-administered
items, rated on a 6-point scale so the score varies between 22 to 132, which assess
psychological and general well-being of respondents in six health related quality of
life (HRQoL) domains: anxiety, depression, positive well-being, self-control,
general health and vitality. The higher scores indicate better quality of life.   Anthropometric measurements were also recorded. Height was measured with the
participants standing without shoesand was recorded to the nearest of 0.5 cm. Weight
was measuredusing a digital scale, with the participants wearing light cloths, and
was recorded to the nearest 100 grams.   Five milliliters of peripheral fasting blood was collected during 2nd or
3rd days of menstrual cycle (follicular phase) from all the subjects
before yogic intervention for baseline investigations and after six months. For
estimation of hormonal profile, serum was separated by centrifuge machine (3500-4000
rotations/minute) at room temperature.   The following kits were used for the estimation of the parameters studied – TSH
ELISA by RFCL Ltd. SIDCUL, Haridwar Uttarakhand, FSH, LH, Prolactin ELISA by Dialab
Ges. M.B.H., Estradiol, Progesterone, Testosterone by Syntron Bioresearch, Inc., and
DHEA-S ELISA by Adaltis Italia S.P.A. The laboratory tests were performed in the
Department of Pathology, King George's Medical University U.P Lucknow. External
quality assurance service to the laboratory was provided by the Bio RAD and internal
assurance was also procured. Elisa reader was used for measuring the variables taken
in the study.   Yoga Nidra intervention: the Yoga Nidra intervention was originally developed by
Swami Satyananda Saraswati, School of Yoga, Munger, Bihar, India.11 Yoga instructor was selected by an
expert panel for this study. The yoga classes for the patients consisted of 30 to 35
minute /day session, five days in week where Yoga Nidra taught by a trained Yoga
Therapist at the Department of Physiology King George's Medical University, Lucknow,
Uttar Pradesh for first three months. Thereafter the patients were advised to
continue the same at their homes for next three months; the yoga lasted for 6 months
in the intervention group. Also, a diary provided to them for noting the schedule of
home based practice was verified. The details were cross checked with attendant
accompanying.   Statistical analysis was done using GraphPad InStat version 3.05 software Inc. year
2000. Paired t-test was used to determine the mean difference scores of all the
parameters of the subjects at baseline and after six months in both intervention and
control groups. The differences in pre and post intervention scores were used for
the analysis. This was done to take into account the imbalances, if any, at the
baseline characteristics of the subjects. The independent t-test was used to compare
the differences in scores between the groups (yoga vs. non yoga group).15,16

BODY.RESULTS:
 Out of 100 subjects, 5 subjects from intervention group and 8 subjects from control
group were considered drop outs.   Out of 13 drop outs, 8 patients could not follow the time schedule and 5 were not
willing to continue as research subjects after one week. Out of 50 subjects from the
intervention group, 45 subjects attended Yoga Nidra sessions till end (completed at
least 80% classes of Yoga Nidra). One of the patients who dropped out in later part
of the study reported non-restorative sleep after first four to five days of
initiating the Yoga Nidra practices. Another lady who discontinued found it
difficult to find time for the practicing Yoga Nidra. The numbers of subjects
completing the study were 45 and 42 in intervention and control groups,
respectively. The Mean (SD) age of women was 26.57 (7.45) years in the intervention
group, and 25.52 (6.27) year for control group.   Table 1 and 2 shows baseline and post intervention PGWBI scores and hormonal profile
of both intervention and control groups. The mean score of anxiety, depression,
positive well-being, general health, and vitality scores in posttest were
significantly different in intervention group as compared with pretest (P<0.05)
(Table 1).   But there were no significant differences in control group. Table 2 depicts the significant differences in The mean of
hormonal level including Thyroid-Stimulating Hormone, Follicle-Stimulating Hormone,
Luteinizing Hormone, Prolactin within intervention group was significantly different
in posttest as compared with posttest (P<0.05). But there was no significant
differences in control group (P>0.05) (Table
2).   Table 3 and 4 depicts comparison of mean differences in PGWBI scores and hormonal
profile. Significant improvement in domains of anxiety (P<0.01), depression
(P<0.02), positive well-being (P<0.01), general health (P<0.04) and
vitality (P<0.02) in intervention group was noted after six months of yogic
intervention when compared to control group (Table
3).   There was no statistical difference in domain of self-control in intervention group
when compared control group (Table 3). We
found significant changes in thyroid-stimulating hormone (P<0.02),
follicle-stimulating hormone (P<0.01), luteinizing hormone (P<0.001) and
prolactin (P<0.03) in intervention group as compared to control group (Table 4).    Table 1 Mean of scores of PGWBI (psychological general well-being schedule index)
at baseline and after six months in intervention and control groups (paired
t-test) 
 
 Intervention group, (N=45) 
 
 Control group, (N=42) 
 
 
 Baseline 
 
 Post-test 
 
 t 
 
 P 
 
 Baseline 
 
 Post-test 
 
 t 
 
 P 
 
 Anxiety 
 14.1 (3.35) 16.2 (3.30) 3.24 0.02 14.3 (4.15) 14.9 (4.60) 1.74 0.5 
 Depression 
 9.25 (2.11) 10.7 (1.30) 2.56 0.02 9.35 (2.91) 9.85 (2.53) 1.61 0.1 
 Positive well-being 
 11.3 (2.43) 12.8 (1.63) 2.65 0.01 11.2 (1.93) 11.37 (3.48) 1.21 0.3 
 Self-control 
 9.0 (2.40) 9.1 (2.19) 2.50 0.07 9.28 (2.71) 9.98 (2.61) 1.32 0.3 
 General health 
 9.08 (2.87) 10.1 (2.81) 2.61 0.04 9.37 (3.02) 9.98 (2.71) 1.11 0.2 
 Vitality 
 11.2 (2.81) 12.3 (2.54) 2.11 0.03 10.9 (2.53) 10.88 (3.21) 1.52 0.2   Table 2 Mean of hormonal profile at baseline and after six months in intervention
and control groups (paired t-test) 
 
 Intervention group, (N=45) 
 
 Control group,(N=42) 
 
 
 Baseline 
 
 Post-test 
 
 t 
 
 p 
 
 Baseline 
 
 Post- test 
 
 t 
 
 P 
 
 TSH  (µlU/ml) 3.80 (2.03) 2.36 (1.82) 5.93 0.001 3.42 (2.27) 3.17 (2.00) 1.20 0.3 
 FSH  (µlU/ml) 17.03 (7.72) 16.16 (6.88) 5.02 0.01 16.16 (7.55) 16.04 (4.96) 1.71 0.4 
 LH  (mlU/ml) 19.23 (10.47) 17.40 (8.70) 9.37 0.002 18.99 (8.18) 18.14 (7.91) 1.51 0.2 
 Prolactin  (ng/ml) 16.42 (6.86) 15.59 (6.37) 8.37 0.01 15.94 (5.63) 15.28 (6.91) 1.72 0.6 
 Progesterone  (ng/ml) 7.27 (7.17) 7.82 (7.26) 9.51 0.08 8.35 (7.83) 8.95 (7.51) 1.71 0.4 
 Estradiol  (Pg/ml) 112.56 (73.80) 113.8 (66.94) 23.64 0.14 113.36 (69.06) 113.54 (68.99) 1.34 0.4 
 Testosterone  (ng/ml) 1.71 (1.28) 1.55 (1.13) 4.42 0.26 2.90 (1.75) 2.23 (1.68) 1.42 0.1 
 DHEA-S  (µg/ml) 1.79 (0.81) 1.43 (0.81) 4.01 0.35 1.92 (1.02) 1.74 (1.03) 1.65 0.6  TSH: Thyroid-stimulating Hormone, FSH: Follicle Stimulating Hormone, LH:
Luteinizing Hormone and DHEA-S: Dehydroepiandrostone Sulfate   Table 3 Comparison of mean differences in PGWBI between intervention and control
groups (independent sample t-test) 
 
 Intervention group 
 
  (N=45) 
 
 Control group 
 
 (N=42) 
 
 t 
 
 p 
 
 Anxiety 
 0.75 (0.42) 0.57 (0.22) 2.30 0.01 
 Depression 
 0.78 (0.45) 0.43 (0.22) 2.12 0.02 
 Positive well-being 
 0.85 (0.33) 0.62 (0.40) 2.16 0.01 
 Self-control 
 0.55 (0.22) 0.64 (0.33) 0.18 0.7 
 General health 
 0.90 (0.33) 0.67 (0.22) 1.68 0.04 
 Vitality 
 0.52 (0.11) 0.31(0.18) 1.18 0.02   Table 4 Comparison of hormonal profile (student’s independent sample t-test)
between intervention and control groups 
 Variables 
 
 Intervention group  
 
 (N= 45) 
 
 Control group 
 
 (N=42) 
 
 P 
 
 TSH  (µlU/ml) 0.54 (0.61) 0.18 (0.97) 0.02 
 FSH  (mlU/ml) 1.72 (2.27) 0.75 (0.48) 0.01 
 LH  (mlU/ml) 1.46 (1.21) 0.52 (2.17) 0.001 
 Prolactin  (ng/ml) 1.66 (1.32) 1.34 (1.35) 0.03 
 Progesterone  (ng/ml) 1.39 (1.34) 1.41 (1.39) 0.09 
 Estradiol  (Pg/ml) 2.04 (1.78) 2.33 (1.49) 0.30 
 Testosterone  (ng/ml) 0.52 ( 0.67) 0.67 (1.07) 0.24 
 DHEA-S  (µg/ml) 0.28 ( 0.67) 0.15 (0.37) 0.27  TSH: Thyroid-stimulating hormone, FSH: Follicle stimulating hormone, LH:
Luteinizing hormone and DHEA-S: Dehydroepiandrostone Sulfate 

BODY.DISCUSSION:
 The present study revealed significant improvement in anxiety scores after six
months of intervention with Yoga Nidra in intervention group in comparison to
control group. Previous studies have also shown significant reduction in the trait
anxiety scores following meditation17 and breathing exercises.18 Studies have also reported reduction in state anxiety
following muscle relaxation techniques and listening to music.19 During anxiety, there is an
increased response of hypothalamus and heightened sympathetic activity. Yoga Nidra
appears to regulate hypothalamus, in a way resulting in decreased sympathetic
(excitatory) nervous activity and increased parasympathetic (inhibitory)
function.11 In the
intervention group which practiced Yoga Nidra for six months, there was significant
decrease in their degree of depressive symptoms (according to the psychological
general wellbeing Index). Other studies also have shown that those with depression
could be benefited from Sudarshan Kriya and related practices.20   Previous studies have also shown that using yoga interventions in other conditions
(cancer survivors, self-reported emotional distress), found to be effective in
depressive and mood symptoms, as well as anxiety and physical well-being.21   The results showed that there was a significant improvement in positive wellbeing,
general health and vitality in intervention group. Yoga Nidra is believed to balance
psychic and vital energies within the psychic channels (Nadis) of the energy
framework underlying the physical body.   Free flow of these energies is considered to be the basis of optimal physical and
mental health. Findings from other studies also is in line with present
study.22-24   However, in domain of self-control there was no statistically significant
difference, but in intervention group there was more improvement in this parameter
when compared to the control group. However, previous studies have found significant
improvement in self-esteem with Yogic exercises.25   Furthermore, the results showed that Yoga Nidra intervention program decreased
depressed mood, feelings of guilt, insomnia, genital problems, tension, fear and
anxious mood which are symptoms included as items of PGWBI.   Subjects experienced better control over their feelings. Previous studies have also
shown the beneficial effects of one week of yoga program in self rated fear,
anxiety, sadness and disturbed sleep in tsunami survivors of the Andaman Islands.
There was a significant decrease in self rated fear, anxiety, sadness and disturbed
sleep, respiratory and heart rate was also significantly improved.26   There was significant change in TSH, FSH, LH, and Prolactin levels in intervention
group as compared to the control group. Previous studies found that long term
practice of yoga lead to decreased TSH, growth hormone, and prolactin imbalances
significantly. Metabolic effects of meditation (Yoga Nidra) includes a decreased
adrenocortical activity, long term decreased cortisol secretion and lesser thyroid
stimulating hormone (TSH) abnormalities.27   Metabolic effects of meditation (Yoga Nidra) includes a decreased adrenocortical
activity, long term decreased cortisol secretion and decreased thyroid stimulating
hormone (TSH). Imbalances in the hormonal profile also predispose women to
depression, especially in relation to pituitary, thyroid and reproductive hormones.
The practice of hatha yoga and Asanas has been found to be extremely effective in
rectifying the situation.12   Menstruation is dependent on the proper functioning of the chain made up of
hypothalamus- pituitary-ovary and uterus.   Pituitary hormones, follicle stimulating hormone (FSH), luteinizing hormones (LH),
prolactin and thyroid hormones are required for normal development of ova and need
to be investigated in cases of chronic anovulation oligomenorhea and
amenorrhea.28 It was
inferred that after Yoga Nidra practice, patients acquired relief in heavy bleeding
and irregular menstrual periods. As other research project, our study has some
limitations.   The main limitation was that amenorrhea, dysmenorrhea, oligomenorrhea,
polymenorrhea, menorrhagia, metrorrhagia, and hypo menorrhea were included in the
study all together. The sample size was not large enough to analyze the
hypomenorrhic group and hypermenorrhic subgroups separately. The information of the
menstrual cycle was based on the participant's self-reports not based on ultrasound
scans; this is also another limitation of the study. In future this study could be
repeated in other populations with large number of patients. Further, some other
yogic practices may be tried and compared with the present ones.

BODY.CONCLUSION:
 Yoga Nidra can be an effective practice to overcome the psychiatric morbidity
associated with menstrual irregularities apart from bringing the hormonal profile
towards normalcy. Therefore, Yogic relaxation training (Yoga Nidra) could be
prescribed as an adjunct to conventional drug therapy for menstrual dysfunction.

BODY.ACKNOWLEDGMENTS:
 We are very thankful to entire yoga team and faculty of department of physiology,
department of geriatric mental health, department of obstetrics & gynecology,
and King George's Medical University U.P Lucknow. The financial support was received
from department of AYUSH, ministry of health and family welfare, government of
India.

BODY.ETHICAL ISSUES:
 None to be declared.

BODY.CONFLICT OF INTEREST:
 The authors declare no conflict of interest in this study‏.

Question: Compared to Prescribed medication without yogic intervention what was the result of Yogic intervention and medication on Positive well-being and vitality scores?
Evidence: Significant improvement in domains of anxiety (P<0.01), depression
(P<0.02), positive well-being (P<0.01), general health (P<0.04) and
vitality (P<0.02) in intervention group was noted after six months of yogic
intervention when compared to control group (Table
3).   
Answer: significantly increased