Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms

NCT06307119 | Completed

• 1 other identifier: 2020-01
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• The Model of Human Occupation Screening Tool (MOHOST)

  30 minutes

Other Outcomes (1)

• Premenstrual Symptom Screening Tool

  10 minutes

Study Arms (3)

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

Relaxation Group BEHAVIORAL

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.

Relaxation Group

Occupational Therapy and Relaxation Group BEHAVIORAL

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.

Occupational Therapy and Relaxation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkey

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 2, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)