NCT06370429

Brief Summary

Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media. 3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants. Criteria for inclusion in the study:

  • Being married and living with his wife
  • Being between the ages of 18-45,
  • The woman's ability to use a mobile phone and/or computer to receive online
  • The woman and her husband must be literate
  • The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome. Exclusion criteria from the study:
  • He or his spouse fills out the research survey forms incompletely,
  • Pregnancy occurs,
  • Receiving breathing exercise consultancy from another consultant during the study period

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 12, 2024

Last Update Submit

May 2, 2024

Conditions

Keywords

Premenstrual SyndromeProgressive RelaxationStress LevelFamily Functionality

Outcome Measures

Primary Outcomes (3)

  • Premenstrual Syndrome Scale

    It is a 44-item, five-point Likert-type scale (Never, Very little, Sometimes, Frequently, Continuously) developed by Gencdogan and measures the severity of premenstrual symptoms. In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option is evaluated as 2 points, the "Sometimes" option is evaluated as 3 points, the "Often" option is evaluated as 4 points and the "Always" option is evaluated as 5 points. The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the more intense the premenstrual syndrome symptoms are considered.

    The research period for a participant takes approximately 3 months.

  • Family Assessment Scale

    Its original form was developed by Brown University and Butler Hospital in the United States within the framework of the Family Research Program. The family evaluation scale consists of 60 (sixty) questions and 7 sub-dimensions. It is a scale with four options and each item is scored between 1.00 (healthy) and 4.00 (unhealthy). Minimum 60 and maximum 240 points are taken from the scale. As the score increases, it indicates that family functionality is not good.

    The research period for a participant takes approximately four months.

  • Perceived Stress Scale

    Perceived Stress Scale (PSS) Cohen consists of 14 items in total. The scale is a five-point Likert type in which each item is scored between "Never (0)" and "Very often (4)". The total score obtained from the scale ranges from 0 to 56, and the score obtained from 11 to 26 is considered low; 27-41 is medium; 42-56 indicates high stress level.

    The research period for a participant takes approximately four months.

Study Arms (2)

Progressive Relaxation Exercises

EXPERIMENTAL

Progressive Relaxation Exercises, randomized pretest-posttest

Other: Progressive Relaxation Exercises, randomized pretest-posttest

control

NO INTERVENTION

Non-intervention

Interventions

experimental and control ,a randomized pretest-posttest study to examine

Progressive Relaxation Exercises

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study,
  • Being married and living with his wife
  • Being between the ages of 18-45,
  • The woman's ability to use a mobile phone and/or computer to receive online (Zoom; vs) counseling and listen to exercises,
  • The woman and her husband have a application or e-mail address that can use the googledocs application.
  • The woman and her husband must be literate
  • The woman does not have a hearing problem that would prevent her from understanding the voice recording,
  • Scoring 110 or above on the Premenstrual Syndrome Scale
  • Having regular menstrual cycles for the last six months,
  • Not having undergone bilateral oophorectomy or hysterectomy,
  • Not having been diagnosed with polycystic ovary syndrome,
  • Having no other medical disease in the last six months,
  • Participant who does not use oral contraceptives,
  • Without severe psychosomatic disorder,
  • Not pregnant or breastfeeding,
  • +4 more criteria

You may not qualify if:

  • He or his spouse fills out the research survey forms incompletely,
  • Wanting to leave the research at any stage of the research,
  • Not participating in the final test,
  • Pregnancy occurs,
  • Receiving breathing exercise consultancy from another consultant during the study period
  • Those who do the relaxation exercises incorrectly according to the Content of the Progressive Relaxation Exercises CD,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Tuba NU KORKMAZ ASLAN

    Necmettin Erbakan University

    STUDY CHAIR
  • Gazi ÇU Kısa

    Cukurova University

    STUDY CHAIR

Central Study Contacts

Ayşe Sevim SU Akbay Kısa

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample was divided into intervention and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 17, 2024

Study Start

May 15, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations