Premenstrual SyndromeNCT06307119
Model of Human Occupation-Based Intervention on Premenstrual Syndrome Symptoms
A study testing Occupational Therapy and Relaxation Group and Relaxation Group in people with Premenstrual Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Occupational Therapy and Relaxation Group and Relaxation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 2 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Model of Human Occupation-Based Intervention on Occupational Participation in Individuals With Premenstrual Syndrome Symptoms
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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Occupational Therapy and Relaxation Group, Relaxation Group
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy and Relaxation GroupBehavioural
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.
Relaxation GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy and Relaxation Group | Experimental | MOHO Based Intervention and Jacobson's Progressive Muscle Relaxation method Receives: Behavioral: Occupational Therapy and Relaxation Group |
| Relaxation Group | Experimental | Jacobson's Progressive Muscle Relaxation method Receives: Behavioral: Relaxation Group |
| Control Group | No intervention | No İntervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkan Torpil, PhD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307119
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Model of Human Occupation-Based Intervention on Occupational Participation in Individuals With Premenstrual Syndrome Symptoms
- ClinicalTrials.gov ID
- NCT06307119
- Acronym / sponsor ID
- 2020-01
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy and Relaxation Group | Experimental | Behavioral: Occupational Therapy and Relaxation GroupMOHO Based Intervention and Jacobson's Progressive Muscle Relaxation method |
| Relaxation Group | Experimental | Behavioral: Relaxation GroupJacobson's Progressive Muscle Relaxation method |
| Control Group | No intervention | –No İntervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapy and Relaxation GroupMOHO 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. | Behavioural | Occupational Therapy and Relaxation Group |
| Relaxation GroupJacobson'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. | Behavioural | Relaxation Group |
Primary outcome
Occupational Self-Assessment
Time frame: 20 minutes
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.
1 secondary outcome
The Model of Human Occupation Screening Tool (MOHOST)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Relaxation Group and Relaxation Group in people with Premenstrual Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Self-Assessment (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.