Impact of a mindfulness stress management program on stress, anxiety, depression and quality of life in women with polycystic ovary syndrome: a randomized controlled trial

Figures & data

Figure 1. Participants’ flow chart.

Table 1. Baseline and post-intervention data (demographic and clinical characteristics, questionnaire scoring and salivary cortisol data) of study participants.

	Intervention group (n = 23)	Control group (n = 15)	95% CI/χ^2, df	p value
Age (years) mean ± SD	23.4 ± 4.62	28.3 ± 7.20	−9.04, 0.93	0.170
Weight (kg) mean ± SD	59.5 ± 6.87	65.2 ± 14.8	−12.99, 1.69	0.127
Body mass index (kg/m^2) mean ± SD
Baseline	21.53 ± 2.15	23.7 ± 4.4	−4.92, 0.45	0.097
Post-intervention	21.37 ± 1.89	23.62 ± 3.98	−4.65, 0.15	0.065
Marital status n (%)
Single	23 (100%)	12 (80%)	χ^2= 4.994, df = 1	0.054
Married	0 (0%)	3 (20%)
Divorced/Separated	0 (0%)	0 (0%)
Educational level n (%)
Primary education	0 (0%)	0 (0%)	χ^2= 2.88, df = 4	0.509
Lower secondary education	0 (0%)	1 (6.7%)
Upper secondary education	2 (8.7%)	2 (13.3%)
Post-secondary education	7 (30.4%)	5 (33.3%)
First stage of tertiary education	7 (30.4%)	5 (33.3%)
Second stage of tertiary education	7 (30.4%)	2 (13.3%)
Residence n (%)
Urban	19 (82.6%)	14 (93.3%)	χ^2= 4.262, df = 5	0.307
Rural	4 (17.2%)	1 (6.7%)
Hormonal profile mean ± SD
Prolactin (ng/mL)	7.69 ± 3.61	5.25 ± 3.07	−14.42, 13.72	0.946
LH (mIU/mL)	6.35 ± 2.64	4.8 ± 1.16	−2.15, 7.01	0.247
FSH (mIU/mL)	13.16 ± 7.41	13.51 ± 7.17	−0.63, 3.66	0.150
Testosterone (nmol/L)	0.455 ± 0.22	0.732 ± 0.51	−0.67, 0.11	0.156
FG Score	7.73 ± 3.12	7.53 ± 2.19	−1.67, 2.09	0.826
Medication
Nil	8 (34.7%)	5 (33.3%)	χ^2= 4.36, df = 5	0.94
Metformin	11 (47.8%)	9 (60%)
OCPs	1 (4.3%)	0 (0%)
Corticosteroids	0 (0%)	1 (6.66%)
Metformin + Antiandrogens	1 (4.3%)	0 (0%)
Metformin + OCPs	2 (8.6%)	0 (0%)
DASS21 questionnaire mean ± SD
Depression
Baseline	18 ± 8	18.1 ± 12.8	−12.10, 0.80	0.840
Post-intervention	4.34 ± 3.28	17.2 ± 9.99	−18.19, −7.51	0.011*
Anxiety
Baseline	8 ± 8	11.06 ± 7.9	−8.86, 2.37	0.249
Post-intervention	4 ± 4	14.13 ± 6.02	−13.98, 1.62	0.670
Stress
Baseline	12 ± 9	11.4 ± 9	−13.41, 1.3	0.105
Post-intervention	5.04 ± 4.02	19.06 ± 9.61	−19.80, −8.80	0.025*
PSS-14 Questionnaire
Baseline	42 ± 8	39.6 ± 6.9	−2.96, −7.45	0.388
Post-intervention	41.27 ± 11.97	41.57 ± 4.92	−5.45, −4.14	0.240
PCOSQ questionnaire mean ± SD
Emotions
Baseline	35.21 ± 11.7	31.06 ± 14.5	−4.54, 12.84	0.339
Post-intervention	41.27 ± 11.97	26.86 ± 12.19	6.20, 22.60	0.088
Body Hair
Baseline	22.3 ± 9	22.3 ± 9.19	−6.16, 6.11	0.992
Post-intervention	26.18 ± 8.06	19.86 ± 9.84	0.32, 12.30	0.390
Weight
Baseline	21.7 ± 10.21	17 ± 10.6	−2.09, 15.12	0.168
Post-intervention	25.38 ± 8.4	16.13 ± 8.64	3.36, 15.12	0.990
Infertility
Baseline	18.78 ± 8	14 ± 8.1	−7.73, 10.16	0.880
Post-intervention	21.78 ± 6.24	13.13 ± 7.34	4.13, 13.16	0.640
Menstrual Problems
Baseline	16 ± 6.63	14.2 ± 6.1	−2.54, 6.14	0.406
Post-intervention	19.39 ± 6.17	12.64 ± 5.35	2.71, 10.78	0.610
Salivary cortisol concentrations mean ± SD
Cort1 (μg/dl)
Baseline	0.53 ± 0.2	0.75 ± 0.66	−0.58, 0.11	0.187
Post-intervention	0.36 ± 0.12	1.96 ± 0.76	−2.79, −0.39	0.001**
Cort2 (μg/dl)
Baseline	1.96 ± 2.86	2.33 ± 5.11	−2.63, 1.90	0.744
Post-intervention	0.8 ± 0.36	2.45 ± 0.8	−2.87, −0.43	0.025*
Cort3 (μg/dl)
Baseline	0.61 ± 0.72	0.30 ± 0.87	−0.13, 0.60	0.189
Post-intervention	0.4 ± 0.21	0.44 ± 0.28	−0.16, 0.08	0.330
AUCg
Baseline	21.65 ± 19.36	22.31 ± 26.72	−15.31, 14.49	0.674
Post-intervention	11.87 ± 4.8	24.24 ± 2.3	−16.76, 3.54	0.190
AUCi
Baseline	20.61 ± 18.24	23.87 ± 5.7	−32.37, 15.36	0.067
Post-intervention	13.21 ± 6.69	28.31 ± 25	−176.05, 39.28	0.200
Daily life questionnaire (mean ± SD)
Daily routine (score range 12–48)
Baseline	35.95 ± 7.23	35.53 ± 8.27	−4.93, 5.76	0.875
Post-intervention	37.45 ± 6.9	36.2 ± 7.66	−3.79, 6.29	0.410
Total life satisfaction (score range 18–90)
Baseline	61.26 ± 9.97	48.33 ± 7.45	0.98, 4.76	0.001**
Post-intervention	63.8 ± 9.67	48.4 ± 7.87	9.5, 11.2	0.001**
General satisfaction (score range 8–40)
Baseline	25 ± 4.24	21.13 ± 4.29	0.98, 6.98	0.010**
Post-intervention	26.95 ± 5.34	21 ± 4.32	2.6, 9.30	0.031*
Job satisfaction (score range 5–25)
Baseline	15.91 ± 3.56	13.33 ± 3.81	0.11, 5.04	0.410
Post-intervention	16.6 ± 3.14	13.4 ± 3.71	0.86, 5.41	0.55
Relationships satisfaction (score range 5–25)
Baseline	17.04 ± 3.75	14.93 ± 3.19	−0.27, 4.5	0.082
Post-intervention	17.69 ± 3.22	13.8 ± 2.19	1.89, 5.76	0.46

Abbreviations: Cort1, salivary cortisol concentrations at 8 a.m. (at rest – at awakening); Cort2, salivary cortisol concentrations at 8.30 a.m. (30 min after waking up – at rest without employing any activity); Cort3, salivary cortisol concentrations at 8 p.m. (12 h post-awakening); AUC_g, area under the curve with respect to the ground; AUC_i, area under the curve with respect to increase; OCPs, oral contraceptive pills. *p < 0.05; **p < 0.01.

Table 2. Cronbach alpha coefficients for study questionnaires’ internal consistency.

Study questionnaires	Cronbach alpha co-efficient
Daily routine	0.900
Life satisfaction scale	0.902
DASS 21
Depression subscale	0.877
Anxiety subscale	0.801
Stress subscale	0.900
PSS-14	0.772
PCOSQ
Weight subscale	0.912
Body hair subscale	0.889
Emotions subscale	0.903
Infertility subscale	0.900
Menstrual problems subscale	0.685
Credibility and Expectancy	0.549

Table 3. Correlation and linear regression coefficients of the technique application frequency and the outcome measures in the Intervention Group.

Outcome measures	Correlation co-efficient	Linear regression co-efficient	95% CI	p value
DASS21 questionnaire
Depression subscale	0.011	0.005	−0.22, 0.21	0.96
Anxiety subscale	0.036	0.014	−0.2, 0.17	0.87
Stress subscale	0.097	0.043	−0.16, 0.24	0.66
PSS-14 questionnaire	0.086	0.050	−0.318, 0.218	0.70
PCOSQ questionnaire
Emotions subscale	0.358	0.296	−0.075, 0.66	0.11
Body hair subscale	0.547**	0.314	0.083, 0.545	0.010
Weight subscale	0.447*	0.279	0.003, 0.548	0.048
Infertility subscale	0.355	0.158	−0.036, 0.353	0.10
Menstrual problems subscale	0.151	0.067	−0.136, 0.27	0.50
Salivary cortisol concentrations
Cort1	0.032	0.001	−0.011, 0.13	0.91
Cort2	0.119	0.003	−0.013, 0.19	0.68
Cort3	0.075	0.001	−0.008, 0.01	0.79
AUCg	0.370	0.037	−0.15, 0.171	0.87
AUCi	0.123	0.123	−0.161, 0.27	0.55
Daily life questionnaire
Daily routine (score range 12–48)	0.051**	0.424	0.148, −0.699	0.004
Total life satisfaction (score range 18–90)	0.583	0.025	−0.273, 0.224	0.83
General satisfaction (score range 8–40)	0.585**	0.229	0.081, 0.378	0.007
Job satisfaction (score range 5–25)	0.561**	0.129	0.040, 0.218	0.004
Relationships satisfaction (score range 5–25)	0.280	0.05	−0.039, 0.17	0.20

Cort1, salivary cortisol concentrations at 8 a.m. (at rest – at awakening); Cort2, salivary cortisol concentrations at 8.30 a.m. (30 min after waking up – at rest without employing any activity); Cort3, salivary cortisol concentrations at 8 p.m. (12 h post-awakening); AUC_g, area under the curve with respect to the ground; AUC_i, area under the curve with respect to increase. *p < 0.05; **p < 0.01.