Study design and participants
This randomized controlled trial with two parallel groups was performed on 86 postmenopausal women in Tabriz-Iran health centers from March to the end of August 2021.
The inclusion criteria included willingness to participate in the study, having normal menopause, being married, having at least a middle school education, women with less than 10 years of menopause, earning an anxiety score of 4–8 (mild and moderate anxiety), depression score between 5 and 11 (mild and moderate depression), stress score between 8 and 13 (mild and moderate stress) according to DASS questionnaire, having a minimum of 45 years and a maximum of 60. There are also exclusion criteria such as the use of tobacco and alcoholic beverages and herbal medicines, known systemic problems including cardiovascular, gastrointestinal, liver, blood, endocrine, etc., use of any effective drug against flushing (clonidine, methyldopa, gabapentin, selective serotonin reuptake inhibitors, norepinephrine inhibitors, soy isoflavones), participating in relaxation and yoga classes and not using anti-anxiety drugs, not using sedatives including cinnamon and chamomile.
Based on the results of the study of Shariat Moghani et al. , the sample size was calculated 39 people by using the G-power software  for stress variable with considering the M1 = 7.07 (mean score of stress subscale of DASS), M2 = 4.59 (assuming 35% reduction due to intervention), SD1 = SD2 = 4.33, one-sided α = 0.05, and Power = 80%. There were 43 people in each group in the final sample size considering the 10% attrition.
The researcher referred to the health centers of Tabriz for sampling. Then, a list of all women around menopausal ages (45 to 60 years) with their phone numbers and addresses were extracted, menopausal women were called, the goals and methods of the study were briefly explained, and the women were examined for inclusion and exclusion criteria. Due to the spread of the coronavirus and compliance with health protocols, they were also asked to be online in the WhatsApp program at a certain time if they are eligible and willing to participate in the study. The objectives of the research were fully explained in the online session. Written informed consent was obtained in a face to face session if the individual tended to participate in the study, then the Depression, Anxiety, Stress Scale-21 (DASS 21) was completed through interviews with participants.
Menopausal women completed the questionnaire of socio-demographic and obstetric characteristics, Menopause Quality of Life (MENQOL) Questionnaire and Pittsburgh Sleep Quality Index (PSQI Index) through interviews if they obtained anxiety score 4 to 8 (mild and moderate anxiety), depression score 5 to 11 (mild and moderate depression), and stress score 8 to 13 (mild and moderate stress). Menopausal women with severe and very severe depression, stress, and anxiety were referred to a psychiatrist.
By using a random blocking method with a 1: 1 allocation ratio, participants were allocated to the intervention (counseling) and control groups. By using Randomiser software , the allocation sequence was determined by a person who did not involve in the study and was not aware of the study process. The type of intervention was written on paper and placed in opaque and sealed envelopes that numbered sequentially to conceal the allocation sequence. The envelopes were opened in the order in which the participants entered the study and the type of group of individuals was determined.
For the intervention group, the researcher (first author) held counseling sessions. The counseling sessions were held face to face in a place intended for counseling with a quiet and private environment in health centers. There were 8 counseling sessions. During the sessions, women were given the necessary information, and there were interactive sessions between the counselor and the women. Counseling was performed with an approach based on ACT, during 60–90 min sessions and one session per week, in groups of 8–12 people. It was also held in a place with a suitable space to observe the social distance, proper air conditioning and the observance of health protocols. No one was infected with Covid-19 during study.
Here is the treatment plan of the counseling group meetings:
Session 1: Greeting with members, description of rules and duties of group members, statement of goals, the introduction of counseling based on ACT. General assessment: the main complaint of the participants, identifying the experimental avoidances of the participants, identifying thoughts and feelings behind these actions, identifying the strengths of the participants.
Session 2: Brief description of the anatomy and physiology of the reproductive system (uterus, ovaries, etc.), the definition of menopause, explanation of menopausal symptoms and their effects on various aspects of life, available drug treatments, and non-drugs methods and their success rates.
Session 3: Teaching mindfulness techniques.
Session 4: The technique of frustration using the metaphor of wells and shovels, the practice of suppressing the mind to show the uncontrollability of the mind; Homework: self-monitoring.
Session 5: Assessing homework, teaching the concept of acceptance: using the metaphor of the guest and teaching the concept of the self-observer. Techniques for not taking seriously the thoughts and practicing them: watching thoughts, taking on the role of a TV reporter, or singing thoughts.
Session 6: Introducing the concept of values and committed actions and the difference between values and purpose and introducing the list of values, using the metaphor of birthday party. Homework: Completing the worksheet of goals, values, and effective actions and obstacles.
Session 7: Start the session with contact with the present moment exercises, control, and evaluation of worksheets, introduction, and training of cognitive inconsistencies, using the metaphor of bus.
Session 8: Repetition of mindfulness techniques and retrieval of assignments and review of exercises.
No intervention was applied to the control group and they received only routine care included: control of blood pressure and weight gain, control hot flushes and other menopausal symptoms, breast exam, pelvic exam, prescription to undergoing mammography and Papsmear test . Also, after the completion of the project, the content of the counseling sessions was provided to the participants of the control group.
Data collection tools
To collect data, the socio-demographic and obstetrics characteristics questionnaire, DASS 21, MENQOL and PSQI were used in this study. The researcher completed the questionnaire before and immediately after the intervention through interviews with participants.
Socio-demographic and obstetrics characteristics questionnaire
This questionnaire includes questions such as age, duration of menopause, menopausal age, level of education, occupation, level of education and occupation of spouse and adequacy of family monthly income for living expenses, number of family members, the relation of people living with participant (living with the daughter-in-law and son-in-law), body mass index (BMI), cigarette smoking in the participant and her spouse and life satisfaction. Content and face validity were used to determine the validity of the socio-demographic and obstetrics characteristics questionnaire. The questionnaire was given to the faculty members. Based on the feedback received, the corrections were made on the tools after collecting their opinions.
In this study, to measure specific criteria for the quality of life of postmenopausal women, the MENQOL questionnaire was used. The medical department of the University of Toronto, Canada (1996) prepared and used this questionnaire. MENQOL has been previously used in Iran and in the Yazdkhasti et al.’s study , the test-retest analysis method was used to determine the reliability this questionnaire and correlation coefficient (r) was reported equal to 0.84. The questionnaire has 29 closed questions with a rating range of zero to six based on the Likert scale. It includes 4 dimensions, vasomotor (3 questions), psychosocial (7 questions), physical (16 questions), and sexual (3 questions). The quality of life score of menopausal women is calculated from the scores obtained from these 4 subdomains. The minimum and maximum scores obtained in the vasomotor dimension are 0 to 18, psychosocial 0 to 42, physical 0 to 96, and sexual 0 to 18 based on how to score on a 6-point Likert scale and the number of questions available. According to mentioned dimensions, the total score of quality of life is from 0 to 174. High scores indicate more severe menopausal symptoms and lower quality of life in postmenopausal women .
This questionnaire includes 18 questions and seven components including subjective sleep quality, sleep latency, sleep duration, sleep efficacy, sleep disturbances, use of sleep medication and daytime dysfunction. The score of each question is between 0 and 3 and the score of each component is a maximum of 3. The sum of the average scores of these seven components is the total score of the instrument, which ranges from 0 to 21. The quality of sleep is lower if the score obtained becomes high. A score higher than 5 indicates poor sleep quality . The Iranian version of this questionnaire is a valid and reliable tool for measuring sleep quality. According to Nazifi et al., the reliability of this instrument with Cronbach’s alpha was reported to be 0.55 .
This scale includes three subscales of stress, depression, and anxiety. This questionnaire consists of 21 questions. For each of the three subscales, 7 questions are considered [48, 49]. The scoring for each question is based on the Likert scale from never (0) to very high . The score is calculated for each scale separately and the overall score is not calculated. For each subscale, the minimum score is zero and the maximum is 21 and a higher score indicates a worse situation . The DASS 21 scale can diagnose and screen symptoms of anxiety, depression, and stress over the past week. Menopausal women aged 45–60 years entered the study who received an anxiety score of 4–8 (mild and moderate anxiety), a depression score between 5 to 11 (mild and moderate depression), and a stress score between 8 to13 (mild and moderate stress) from DASS questionnaire. This questionnaire was also validated In Iran and its validity was reported for anxiety subscale 0.73, depression subscale 0.81, and stress subscale 0.81 .
The data were analyzed using SPSS-Version 24 software after collecting information from all participants. The normality of quantitative data was assessed using the Kolmogorov – Smirnov test. Chi-square, chi-square for trend, independent t, and Fisher’s exact tests were used to compare socio-demographic and obstetrics characteristics between the two groups. An independent t-test was used to compare the mean score of variables with normal distribution among study groups. Mann-Whitney U test was used for variables with the non-normal distribution. Within group comparisons were conducted using the Wilcoxon test for variables with the non-normal distribution and paired samples t-test for variables with normal distribution.
All tests were performed based on Intention-To-Treat. P < 0.05 was considered significant.