Design:
This study is a randomized controlled clinical trial. It is registered in the Iranian clinical trials database under the code IRCT20211216053423N1 in 14/03/2022. The research population consisted of women suffering from stress urinary incontinence who attended a specialized women's clinic in Mashhad from May 2022 to September 2022 whit research project code 4000965. Permission to conduct research projects under the Code of Ethics (IR.MUMS.NURSE.REC.1400.092) was obtained from Mashhad Medical University. Sampling was conducted at two pelvic floor disease specialty clinics, Qaim Hospital and Imam Reza Hospital, Mashhad. The inclusion Criteria for participation in this study required informed consent, being Iranian, being at least 18 years old, having a minimum level of literacy, having a smartphone, not being pregnant, having no known disease associated with urinary incontinence4, not using drugs or diuretic5 herbs, not consuming alcohol, not smoking or abusing substances, no mobility restrictions6, verbal communication abilities, BMI less than 30, no urinary tract infections7, suffering from stress urine incontinence (based on a score of 4 or above on the first three questions of the QUID questionnaire) and no signs of severe stress, anxiety, or depression8 (as measured by the Depression, Anxiety and Stress Scales DASS 21). The researcher identified every woman who visited the clinic complaining of urinary incontinence. If they met the study participation criteria and wished to participate, they were asked to read and sign a written informed consent form after the researchers outlined the research objectives and introduced themselves. Participants were also informed that any data collected from them would be treated as confidential information.
The withdrawal criteria during the study included failure to attend multiple counseling sessions, unwillingness to continue participating, and an unfortunate accident9 during the study.
The sample size is based on the study of Khosravan et al. (2014), considering the intervention nature of the study, the ability to use methods with high statistical power, and the possibility of dropping samples; based on the effect size formula, considering 5% error and 80% test power and average effect size (0.7), 32 people and including 10% attrition, 35 people were determined in each group (23). After determining the sample size and selecting the samples, the samples were randomly assigned to either the control or intervention groups using permutated blocks with a block size of two.
The following tools were utilized in this study:
The demographic information form: This questionnaire comprised ten questions about personal qualities and eight questions about physical condition. This form was prepared based on extensive literature review. The validity of its content was confirmed by seven experts and members of the scientific board of Mashhad University of Medical Sciences. Researcher completed this form through interviews and observations of each research unit.
Questionnaire for Urinary Incontinence Diagnosis (QUID): This questionnaire contains six questions; a score of four or higher on the first three questions indicates stress incontinence; a score of six or higher on the second three questions indicates urgency urinary incontinence; and the presence of both cases indicates mixed-type incontinence (24). In the present study, only people suffering from stress were selected. The validity of this questionnaire construction in Iran was verified by Mokhlesi et al. (2017) and carried out using exploratory and confirmatory factor analysis (25). In the present study, content validity was performed and its reliability was confirmed by calculating Cronbach's alpha coefficient of 0.86.
Incontinence Quality of Life Instrument (I-QOL): This questionnaire includes 22 questions and three dimensions. 1- Avoidance and limiting behavior (eight items, comprising items 1, 2, 3, 4, 10, 11, 13, 20) 2- Psychosocial impacts (nine items including items 5, 6, 7, 9, 15, 16, 17, 21, 22) 3- Social embarrassment (five items including items 8, 12, 14, 18, 19). All survey questions are rated on a Likert scale from 1 to 5. A score of 1 to 5 is granted for options ranging from 'strongly' to 'never'. The corresponding formula to gain the total score is 0-100. Higher values indicate better quality of life (26). The translation and validity of this questionnaire were evaluated by Nojomi et al. (2009) in Iran (27). In the current study, the questionnaire's validity was confirmed by the content validity and reliability by calculating the Cronbach alpha coefficient of 0.96.
Depression, Anxiety and Stress Scales (DASS-21): This questionnaire contains 21 questions about anxiety, depression, and stress. Each of the three subscales of depression, anxiety, and stress is measured with seven items. And the subject's score in each subscale is calculated by the sum of the expressions corresponding to all the subscale expressions. Each question is scored on a 4-point Likert scale ranging from not at all to a lot (0 to 3). The minimum and maximum scores for depression, anxiety, and stress are 0 and 21, respectively. The validity of the Persian version of this tool was determined by Sahebi et al. (2004) in Mashhad (28). In this study, the validity of content validity and its reliability were confirmed by calculating Cronbach's alpha coefficients of 0.87.
Intervention:
A pre-test was performed for both the intervention and control groups by completing the research tools. There was no drop in samples in either group until the completion of the intervention (Figure 1). The intervention was in the form of counseling and the validity of the content was confirmed by seven faculty members of Mashhad University of Medical Sciences. The intervention included group counseling based on Pender's health promotion model constructs (Table 1), which was delivered once a week for six weeks in groups of seven persons. The initial and last meetings were held in person. Other group counseling sessions were held online in Sky Room for 45-60 minutes. The control group received the standard treatment, which included a visit from a gynecologist with a pelvic floor fellowship.
Table 1: Schedule and content of group counseling sessions based on Pender's health promotion model on quality of life
Sessions
|
Subject
|
Content
|
First session
|
- Structure of individual characteristics and experiences
- A brief summary of urine incontinence-related behaviors
|
- Familiarizing the members with each other, stating the objectives of the course
- Encouraging group members to share their experiences with urinary incontinence
- Motivating people to learn more about urinary incontinence factors and behaviors
- Encouraging members of the group to participate in the appropriate conversation and share their experiences
- Summing up the counseling session and scheduling the next session
|
Second session
|
- Activity-Related affect
|
- Encouraging group members to discuss their feelings and opinions about practicing urinary incontinence-related actions.
- Summing up the counseling session and scheduling the next session
|
Third session
|
-Self-efficacy infrastructure
- Training for the pelvic floor and bladder control
|
- A discussion on people's abilities to perform urinary incontinence-related behaviors.
-Instructing on pelvic floor exercises and bladder control
- Encouraging people to perform urinary incontinence-related behaviors
- Summing up the counseling session and scheduling the next session
|
Fourth session
|
- The substructures of the perceived barriers and perceived benefits
|
- A group discussion about the challenges and rewards associated with urinary incontinence-related behaviors.
-Encouraging group members to participate to provide solutions for removing obstacles while strengthening the rewards of performing the behavior
|
Fifth session
|
- The substructures of interpersonal influencers and situational influencers
|
- Encouraging people to offer solutions to strengthen interpersonal interactions.
- Group members’ discussion on how to improve the situation by offering suggestions.
- Summing up the counseling session and scheduling the next session
|
Sixth session
|
- The substructure of commitment to plan and the structure of behavioral outcomes
|
- People should express their intention to engage in urinary incontinence-related activities.
- A brief assessment of the contents expressed by group members in previous meetings
- Completing questionnaires by group members
- Counseling session synopsis
-Many thanks to everyone in the group.
|
People from both groups completed the questionnaires again immediately and two months after the intervention ended. The data was analyzed using SPSS version 25 and the Kolmogorov Smirnov, independent t, Mann-Whitney, and repeated measure tests.