Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms
NCT ID: NCT06307119
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2023-03-01
2024-03-02
Brief Summary
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Detailed Description
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Participants The study employed a convenience sampling method. Invitation messages were sent via WhatsApp to 2500 undergraduate students within the university's Faculty of Health Sciences, where the study was conducted. A total of 230 participants were enrolled in the study and assessed by a researcher (B.T.). According to the inclusion and exclusion criteria, 125 people were excluded. 105 students were divided into three groups: Control Group, Relaxation Group, and Occupational Therapy and Relaxation Group. During the study, 10 participants-3 from group Occupational Therapy and Relaxation Group and 7 from the Relaxation Group -were unable to complete the intervention program. Consequently, the study was concluded with 95 university students with premenstrual syndrome .
Demographic data were gathered prior to randomization. Participants were randomly assigned (allocation ratio of 1:1) to either the Control Group, Relaxation Group, and Occupational Therapy and Relaxation Group. using computer-generated randomization. All participants underwent a 6-week intervention before and after evaluation, which was conducted by the same researcher who was blinded to the group allocation. No monetary or credit compensation was provided for participation in the study.
The data underwent analysis using the SPSS version 26.0 statistical software package. Normality assessment was conducted using the Shapiro-Wilk test. Group differences were assessed using the chi-square test for nominal data and the Mann-Whitney U test for ordinal data. To compare pre- and post-intervention results within groups, the Wilcoxon signed-rank test was employed. Participants who didn't complete the post-evaluation (n = 10) were excluded. Quade's rank analysis of covariance test was utilized to control baseline disparities in measurements. Effect size was calculated to quantify intervention effectiveness relative to comparisons, utilizing means, standard deviations, and correlation coefficients for within-group changes. Effect size benchmarks of 0.20, 0.50, and 0.80 standard deviations were considered small, medium, and large, respectively, according to Cohen (1992). Statistical significance was defined as p \< .05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Occupational Therapy and Relaxation Group
MOHO Based Intervention and Jacobson's Progressive Muscle Relaxation method
Occupational Therapy and Relaxation Group
MOHO Based Intervention
The client-centered occupational therapy comprises five distinct stages:
1. Client-Centered Goal Setting:It involves collaboratively establishing goals the client's needs and aspirations.
2. Creating the Therapy Plan:Comprehensive therapy plan is devised from the findings from OSA and MOHOST results.
3. Implementing the Interventions:These interventions aimed addressing various personal challenges,financial management,stress management.
4. Evaluating the Results:It involves adjusting the therapy plan as needed based on the participant's responses and outcomes.
5. Receiving Feedback
Jacobson's Progressive Muscle Relaxation
Starting with the lower extremities,participants sequentially tensed and relaxed muscle groups,moving from distal to proximal regions,encompassing toes,ankles,thighs,buttocks,abdomen,fingers,triceps,shoulders,and face.During all these stages,it was ensured to maintain contraction for 5 seconds and to relax and rest for 10 seconds.
Relaxation Group
Jacobson's Progressive Muscle Relaxation method
Relaxation Group
Jacobson's Progressive Muscle Relaxation (JPMR) Participants underwent training in relaxation techniques involving mental visualization and Jacobson's progressive muscle relaxation method with the aid of music. Starting with the lower extremities, participants sequentially tensed and relaxed muscle groups, moving from distal to proximal regions, encompassing toes, ankles, thighs, buttocks, abdomen, fingers, triceps, shoulders, cervical muscles, and face. During all these stages, it was ensured to maintain contraction for 5 seconds and to relax and rest for 10 seconds.
Control Group
No İntervention
No interventions assigned to this group
Interventions
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Occupational Therapy and Relaxation Group
MOHO Based Intervention
The client-centered occupational therapy comprises five distinct stages:
1. Client-Centered Goal Setting:It involves collaboratively establishing goals the client's needs and aspirations.
2. Creating the Therapy Plan:Comprehensive therapy plan is devised from the findings from OSA and MOHOST results.
3. Implementing the Interventions:These interventions aimed addressing various personal challenges,financial management,stress management.
4. Evaluating the Results:It involves adjusting the therapy plan as needed based on the participant's responses and outcomes.
5. Receiving Feedback
Jacobson's Progressive Muscle Relaxation
Starting with the lower extremities,participants sequentially tensed and relaxed muscle groups,moving from distal to proximal regions,encompassing toes,ankles,thighs,buttocks,abdomen,fingers,triceps,shoulders,and face.During all these stages,it was ensured to maintain contraction for 5 seconds and to relax and rest for 10 seconds.
Relaxation Group
Jacobson's Progressive Muscle Relaxation (JPMR) Participants underwent training in relaxation techniques involving mental visualization and Jacobson's progressive muscle relaxation method with the aid of music. Starting with the lower extremities, participants sequentially tensed and relaxed muscle groups, moving from distal to proximal regions, encompassing toes, ankles, thighs, buttocks, abdomen, fingers, triceps, shoulders, cervical muscles, and face. During all these stages, it was ensured to maintain contraction for 5 seconds and to relax and rest for 10 seconds.
Eligibility Criteria
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Inclusion Criteria
* (2) aged 18 years or older
* (3) maintaining a regular menstrual cycle
Exclusion Criteria
* (2) pregnant or breastfeeding
* (3) taking oral contraceptive pills
* (4) receiving hormonal treatment to regulate menstrual cycle
* (5) unable to consistently engage in the intervention program
18 Years
65 Years
FEMALE
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Berkan Torpil, PhD
Associate Professor
Locations
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University of Health Sciences Turkey
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020-01
Identifier Type: -
Identifier Source: org_study_id
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