Design of study and participants
This study is a randomized, controlled trial, based on the CONSORT guideline with single-blinding (the outcomes analyzer was blinded to study groups) and having two parallel arms with 1:1 allocation ratio , conducted on 76 women with endometriosis who were from 15 to 45 years and were hospitalized in Al-Zahra Teaching and Treatment Center of Tabriz in the past 1-3 years. The participants were selected from January 2017 to June 2019. Inclusion criteria were residing in Tabriz, at least secondary school educational level, diagnosed with endometriosis via laparoscopy during the past 1-3 years, being in the age range of 15-45 years, and availability of home and cellphone number. Exclusion criteria were any condition that increased the risk of anxiety and depression (e.g. irritable bowel syndrome), intake of antidepressants in the past 3 months, malignancies according to the patient, a severe depression and a severe anxiety, a recent trauma (e.g. death of relatives or divorce) that increases the risk of developing mental disorders, speech or hearing disorders that complicate communication with the researcher, being pregnant after being diagnosed with endometriosis and a history of current or past mental illness or a history of hospitalization for that.
The sample size was calculated as 35 using the G-Power software based on the study by Waller et al (41) by taking into account the depression variable and the largest standard deviation of depression subscales (m1=11.8, m2= 7.2 with the assumption of 35% reduction in the depression score due to intervention, sd1=sd2=6.6, α=0.05 and power=80%). The sample size was determined as 38 by taking into account 10% sample loss.
Sampling and randomization
The participants were selected after obtaining the license from the ethics committee of Tabriz University of Medical Sciences (ethical code: REC.1397, 625 TBZMED.IR) and registering the study on the Iranian Registry of Clinical Trials (IRCT 20111219008459N13). The researcher visited Al-Zahra Teaching and Treatment Center of Tabriz, prepared a list of women with endometriosis hospitalized in the center during the past 1-3 years based on medical records and contacted the patients through phone calls and explained objectives and design of the project. Then in a face-to-face meeting with eligible patients the objectives and design of the project were fully explained and informed written consent were obtained. The socio-demographic questionnaire, Beck Depression Inventory (BDI-ΙΙ), Spline Berger State-Trait Anxiety Inventory (STAI), and the Quality of Life Questionnaire (SF36) were completed through interviews. The patients with mild to severe anxiety (32-75 state anxiety scores and 32-72 trait anxiety scores) and mild to moderate depression (14-28 depression scores) were enrolled in the study.
The patients were divided into intervention (counselling) and control groups using stratified block randomization (with blocks of 4 and 6) based on infertility history via the www.random website. The intervention was written down on a paper and placed in sequentially numbered opaque sealed envelopes by a person who was not involved in sampling and data analysis to conceal the allocation sequence. The envelopes were given to the participants in order of their arrival and the type of group was determined.
For the intervention group, self-care group counseling was conducted during 7 sessions of 90-60 minutes per week at Al-Zahra Training and Treatment Center in a relaxing and friendly environment and in the native language. Content of the sessions is given here:
First session: In this inducting session, the number and duration of each session, the interval between sessions, and the rules governing the sessions, definition and concept of endometriosis, etiology, diagnostic methods, current treatment methods, and complications were explained to the patients. An educational booklet was distributed among the patients.
Second session: The concept and importance of self-care were explained to the patients in a simple tone. Self-care skills and aspects were also paraphrased.
Third session: Necessary training was given on proper and healthy diet.
Fourth session: The importance of physical exercise in healthy lifestyle and relief of endometriosis symptoms (especially pain) were explained in a simple tone. The proper medication regimen (e.g. timing and amount of medication) was also discussed. The key points were repeated at the end of each session.
Fifth session: Non-pharmacological pain management therapies were explained and the factors that worsen the endometriosis symptoms and harmful practices were also explained and was recommended to be avoided.
Sixth session: The self-care aspects (psychological, social and spiritual) and their impacts on physical and mental health were explained to the participants.
Seventh session: self-care behaviors were practiced.
The control group received routine care. The Beck Depression Inventory, the Spline Berger Anxiety Inventory and SF36 Quality of Life Questionnaire were completed by the researcher through an interview via phone calls four weeks after the intervention (12 weeks after initial assessment).
Data collection tools:
Required data was collected using the above instruments.
Socio-Demographic questionnaire collected data on age, marital status, duration of marriage, number of children, history of infertility, history of treatments for infertility, tendency to get pregnant again, ethnicity, education, occupation, education of spouse, occupation of spouse, adequacy of income to cover living expenses, place of residence, life satisfaction, duration of endometriosis, time of diagnosis, treatment methods, and post-treatment status. This questionnaire was prepared by the researcher. Its content validity was approved by 10 faculty members of Tabriz University of Medical Sciences.
Beck Depression Inventory
The Beck Depression Inventory was developed by Beck et al in 1996. It contains 21 items that assesses all domains of depression based on the cognitive theory of depression. Each item has four options. The individuals reveal their feelings and behaviors by answering each question. Each option is scored from 0 to 3 depending on the severity of symptoms. The range of scores is from 0 to 63. The inventory can be applied to >13 years of age populations since it assesses both incidence and severity of depression. It reflects feelings during the past two weeks. 0<score<13 represent negligible depression, 14<score<19 represents mild depression, 20<score<28 represents moderate depression, and 29<score<63 represents severe depression (42). Rajabi et al. assessed reliability of the Beck Depression Inventory-Second Edition by calculating Cronbach's alpha coefficient. Alphas for the whole questionnaire, the first factors (cognitive-affective) and the second factors (negative attitudes-somatic symptoms) were obtained as 0.86, 0.84 and 0.87 respectively. These alphas were acceptable, which showed homogeneity of the subscales. The correlation coefficients of the whole scale with the first and second factors were 0.90 and 0.95 respectively. The correlation of the first and second factors was obtained as 0.75. These coefficients were significant at p<0.001 significance level (43).
State-trait anxiety inventory (STAI)
This is a standard questionnaire. Its reliability was confirmed in previous studies. The scale used in this study contained 40 self-report items (20 for the state anxiety and 20 for trait anxiety). The state anxiety is scored based on a four-point Likert scale ((1) very low, (2) low, (3) very high, and (4) very high). The trait anxiety is also scored based on a four-point Likert scale ((1) almost never, (2) sometimes, (3) often, and (4) almost always). The minimum and maximum scores were 20 and 80 respectively. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20, 21, 23, 26, 26, 27, 30, 33, 34, 36, 36, 39 were scored inversely (44). In state anxiety, 20<score<31 represents mild anxiety, 32<score<42 represents low to moderate anxiety, 43<score<53 represents moderate to high anxiety, 54<score<64 represents relatively severe anxiety, 65<score<75 represents severe anxiety, and score>75 represents severe anxiety. In trait anxiety, 20<score< 31 represents mild anxiety, 32<score<42 represents low to moderate anxiety, 43<score<52 represents moderate to high anxiety, 53<score<62 represents relatively severe anxiety, 63<score<72 represents severe anxiety, and score>72 represents very severe anxiety. Mahram et al. standardized the scale for Iranian population and calculated the Cranach's alpha as 0.91 (45).
The short form healthy survey (SF-36)
SF36 Quality of Life Questionnaire is the most popular tool for measuring quality of life. It was developed in the United States and translated into different languages. It measures 8 health-related concepts, namely physical functioning (10 items), role limitation due to physical reasons (4 items), physical pain (2 items), public health (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional reasons (3 items), and mental health (5 items). An item indicating changes in public health per year was added to this questionnaire. The score of each dimension was determined by the score of items included in that dimension. The Quality of Life Questionnaire was designed in the United States in 1992. Reliability and validity of the questionnaire was studied by Montazeri et al. in Iran in 2005. They recommended it as a reliable and reliable tool for measuring public health-related quality of life (46).
Reliability of the questionnaires was determined using test-retest on sample of 20 women within a two-week interval by calculating Cronbach's alpha and the intraclass correlation coefficient in the present study. In this study intraclass correlation coefficients of Beck Depression Inventory, State Anxiety Inventory, Trait Anxiety Inventory and SF36 Quality of Life Questionnaire were calculated as 0.91, 0.88, 0.83 and 0.93 respectively. The Cronbach’s alphas were also obtained as 0.87, 0.78, 0.72 and 0.91 respectively.
The collected data was analyzed using the SPSS-Version 21 software. Normality of quantitative data was determined using the Kolmogorov-Smirnov. All variables were normal except the depression. Chi-square, Trend chi-square, Fisher’s exact test and independent t-test were used to assess homogeneity of the groups in terms of personal and social characteristics. The independent t-test was used to compare the mean anxiety, depression and quality of life scores between the two groups before the intervention. ANCOVA was used to compare the scores between the two groups within a four-week interval by controlling the baseline values. The Mann-Whitney U test was used to assess the variables with abnormal distribution. All analyzes were performed based on intention-to-treat method. P<0.05 was considered significant.