Model of Human Occupation-Based Intervention on Premenstr... | NCT06307119

NCT06307119

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Occupational Therapy and Relaxation Group	Experimental	MOHO Based Intervention and Jacobson's Progressive Muscle Relaxation method	Behavioral: Occupational Therapy and Relaxation Group
Relaxation Group	Experimental	Jacobson's Progressive Muscle Relaxation method	Behavioral: Relaxation Group
Control Group	No Intervention	No İntervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occupational Therapy and Relaxation Group	Behavioral	MOHO Based Intervention The client-centered occupational therapy comprises five distinct stages: Client-Centered Goal Setting:It involves collaboratively establishing goals the client's needs and aspirations. Creating the Therapy Plan:Comprehensive therapy plan is devised from the findings from OSA and MOHOST results. Implementing the Interventions:These interventions aimed addressing various personal challenges,financial management,stress management. Evaluating the Results:It involves adjusting the therapy plan as needed based on the participant's responses and outcomes. 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occupational Self-Assessment	The Occupational Self-Assessment(OSA) version-2.2 is tool comprising 21 items,aimed at evaluating both occupational competence and value.Each item within the OSA is rated using two distinct 4-point scales.The first scale measures occupational competence,ranging from 1(indicating significant difficulty) to 4(indicating excellent performance).Conversely,the second scale evaluates value,ranging from 1(indicating low importance) to 4(indicating utmost importance).Subsequently,individual item scores are aggregated to derive total scores for both competence and value,which are then standardized to a scale of 0 to 100 following prescribed guidelines.Higher total scores signify elevated levels of both occupational competence and value.Upon completion of the assessment,participants are prompted by the therapist to identify the four items they consider to be of utmost priority.Turkish version of this instrument underwent validation in a prior study conducted by Pekçetin et al. in 2018.	20 minutes

Secondary Outcomes

Measure	Description	Time Frame
The Model of Human Occupation Screening Tool (MOHOST)	The MOHOST,serves as assessment tool aimed at gauging occupational participation,irrespective of specific diagnoses.MOHOST is structured to measure pertinent concepts derived from the Model of Human Occupation(MOHO).Within this framework,each of the six key concept-denoted as (a)volition or motivation for occupations,(b)habituation or patterns of occupation,(c)communication and interaction skills,(d)process skills,(e)motor skills,and (f)environment-is represented by four distinct items.In the MOHOST each of the 24 items is assessed using a four-point rating scale,focusing on its impact on occupational participation.The ratings are as follows:"F" signifies that the item"Facilitates" occupational participation,"A" indicates that the item "Allows" participation,"I" suggests that it "Inhibits" participation,and "R" denotes that the item"Restricts" participation.Low scores on the MOHOST indicate that occupational participation is restricted.Turkish version of MOHOST developed by Zakarneh.

Other Outcomes

Measure	Description	Time Frame
Premenstrual Symptom Screening Tool	We utilized an instrument developed by Ozdel et al. (2015) to assess premenstrual syndrome (PMS) to DSM-V criteria. This scale comprises 25 items that evaluate symptoms associated with PMS. A unified score is derived from the scale, where symptoms are categorized into three subgroups: Premenstrual Dysphoric Disorder (PMDD), PMS, and normal/non-PMDD. The scale demonstrated a Cronbach's alpha coefficient of 0.928, indicating high internal consistency.

Eligibility Module

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care