NCT05665686

Brief Summary

Sexual health is one of the important factors affecting the quality of life and general health of individuals. Sexual life, with its personal and social aspects, is an inseparable part of the human being in general. It is one of the most important factors in human life and happiness, especially in family life. Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops a personality, communication and love. The concepts of sexuality and sexual health have long been considered taboo. This situation negatively affects rehabilitation strategies. Studies are known to have sexual problems in women more than men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

December 19, 2022

Last Update Submit

February 3, 2025

Conditions

Keywords

woman's healthexercise

Outcome Measures

Primary Outcomes (3)

  • Female Sexual Function Scale

    This scale was developed by Rosen et al. It has been developed by in the United States of America and its main purpose is to address female sexual function in a multifaceted manner. It has been shown to be a valid and reliable diagnostic tool in analyzing sexual functions in Turkish women. FSFI; It consists of 19 questions in total. Scale; There are 6 sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction and pain. Each item is scored from zero to 5. Accordingly, the highest raw score that can be obtained from the scale is 95.0 and the lowest raw score is 4.0.

    six weeks

  • Female Sexual Stress Scale

    This scale was first developed in 2002 in the United States by Derogatis, Pyke, McCormack, Hunter, and Harding to assess women with sexual dysfunction. When filling out the scale, women are asked to describe the frequency of discomfort with the sexual problem they have experienced in the last 30 days. In the society where this 13-item 5-point Likert-type scale was developed, women who score 11 and above are considered to have sexual disorders.

    six weeks

  • Surface electromyography

    With the help of this measurement technique, which contains important information about the contraction of our body muscles, it is checked which muscles are activated in which movement. In our study, muscle activation evaluation will be made with the evaluation of the pelvic floor muscles.

    six weeks

Secondary Outcomes (1)

  • Sexual Life Quality Scale- Female:

    six weeks

Study Arms (2)

Device Group

EXPERIMENTAL

Sexual Information and Advice to Individuals Individuals in both groups will be given training on sexuality. Male and female sexual situation, orgasm, male and female anatomical structures will be explained. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.

Device: Relaxation training with device

home exercise

ACTIVE COMPARATOR

A home exercise program including pelvic floor relaxation exercises in different positions will be created for individuals in both groups and self-myofascial massages will be taught. At the same time, information will be given about the pelvic floor muscles, their function and their importance in sexual life.

Other: Home Exercise

Interventions

Relaxation training will be applied with the device.

Device Group

An exercise application including home exercise programs will be performed for six weeks.

home exercise

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged 18 and over
  • Having an active sex life

You may not qualify if:

  • Latex allergy
  • Other allergies in the pelvic area
  • Vaginal or urinary tract infection
  • Gynecological cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceşehir University Health Center

Istanbul, 34070, Turkey (Türkiye)

Location

Related Publications (1)

  • Salazar de Pablo G, De Micheli A, Nieman DH, Correll CU, Kessing LV, Pfennig A, Bechdolf A, Borgwardt S, Arango C, van Amelsvoort T, Vieta E, Solmi M, Oliver D, Catalan A, Verdino V, Di Maggio L, Bonoldi I, Vaquerizo-Serrano J, Baccaredda Boy O, Provenzani U, Ruzzi F, Calorio F, Nosari G, Di Marco B, Famularo I, Molteni S, Filosi E, Mensi M, Balottin U, Politi P, Shin JI, Fusar-Poli P. Universal and selective interventions to promote good mental health in young people: Systematic review and meta-analysis. Eur Neuropsychopharmacol. 2020 Dec;41:28-39. doi: 10.1016/j.euroneuro.2020.10.007. Epub 2020 Nov 6.

    PMID: 33162291BACKGROUND

MeSH Terms

Conditions

Pelvic Floor DisordersMotor Activity

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist PhD

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 27, 2022

Study Start

January 5, 2023

Primary Completion

February 21, 2023

Study Completion

December 25, 2024

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations