Clinical trial NCT06307119: Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms
Official title: The Effectiveness of Model of Human Occupation-Based Intervention on Occupational Participation in Individuals With Premenstrual Syndrome Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to examine the effect of two different occupational therapy interventions on premenstrual syndrome symptoms in university students. This study was designed according to the CONSORT statement, which provides a standard method for randomised controlled trial (RCT) design. The study was approved by the Local Ethics Committee. Written informed consent was obtained from all participants before the study.

Detailed description: The current study constituted a single-center, two-arm, parallel-group randomized controlled trial involving university students from a public university in Turkey. Prior to study, the research protocol received approval from the local ethics committee. All participants provided written informed consent. The current study was designed according to the CONSORT statement, which provides a standardized method for randomized controlled trial (RCT) design.

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.

Eligibility criteria: Inclusion Criteria:

* (1) diagnosed with Premenstrual Syndrome as per the Premenstrual Symptom Screening Tool (PSST)
* (2) aged 18 years or older
* (3) maintaining a regular menstrual cycle

Exclusion Criteria:

* (1) diagnosed with another psychiatric or gynecological disorder
* (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

Primary outcomes:
measure: Occupational Self-Assessment
timeFrame: 20 minutes
Secondary outcomes:
measure: The Model of Human Occupation Screening Tool (MOHOST)
timeFrame: 30 minutes
Other outcomes:
measure: Premenstrual Symptom Screening Tool
timeFrame: 10 minutes
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References: