NCT06515067

Brief Summary

This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples. It aims to answer the question "Does back massage increase sexual satisfaction and marital harmony in infertile couples?" They will apply infertile chirt back massage and then answer survey questions about sexual satisfaction and marital harmony.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

Study Start

First participant enrolled

November 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 4, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

infertilityback massagesexual satisfaction

Outcome Measures

Primary Outcomes (3)

  • İnfertility stress scale for measuring infertility stres

    It is a scale developed by Schmidt (2006) to evaluate the stress experienced by infertile couples. The scale is a four-point Likert type (1: not at all, 4: very much), consists of 3 dimensions and 14 items.

    2 mouths

  • Marital Adjustment Scale

    The scale not only measures general marital satisfaction or quality, but also evaluates relationship style on issues such as expression of emotions, family budget, agreement or disagreement on issues such as sexuality and social rules, leisure activities, conflict resolution, and trust.

    2 mounths

  • Golumbuok Rust Sexual Satisfaction Scale

    The scale is a measurement tool to evaluate the quality of sexual intercourse and sexual dysfunctions. The total score obtained gives a general idea about the quality of sexual functions, and the subscale scores provide more detailed information about the aspects of the relationship. There are two separate forms prepared for men and women, each consisting of 28 items.

    2 Mounths

Secondary Outcomes (1)

  • COMPI coping with infertility stress scale

    2 mouths

Study Arms (2)

study group

EXPERIMENTAL

People in this group applied back massage

Other: back massage

control group

OTHER

People in this group did not apply back massage

Other: no ıntervention

Interventions

back massage

study group

no ıntervention

control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being 18 years or older, Being diagnosed with infertility, Being married and spouses living together, Being literate, There is no mental or psychological disorder/disability that would affect understanding and perception, Not having a problem that prevents massage (must not be an extremity amputee, should not have a fracture or dislocation, should not have an open wound)

You may not qualify if:

  • Unable to communicate,
  • Couples who do not want to participate in the research will not be included in the research.
  • Individuals who cannot be contacted and do not want to participate in the research will not be included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes Üniversitei

Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (3)

  • Agarwal A, Baskaran S, Parekh N, Cho CL, Henkel R, Vij S, Arafa M, Panner Selvam MK, Shah R. Male infertility. Lancet. 2021 Jan 23;397(10271):319-333. doi: 10.1016/S0140-6736(20)32667-2. Epub 2020 Dec 10.

    PMID: 33308486BACKGROUND
  • Alirezaei S, Ozgoli G, Alavi Majd H. Evaluation of Factors Associated with Sexual Function in Infertile Women. Int J Fertil Steril. 2018 Jul;12(2):125-129. doi: 10.22074/ijfs.2018.5193. Epub 2018 Mar 18.

    PMID: 29707928BACKGROUND
  • Aourell M, Skoog M, Carleson J. Effects of Swedish massage on blood pressure. Complement Ther Clin Pract. 2005 Nov;11(4):242-6. doi: 10.1016/j.ctcp.2005.02.008.

    PMID: 16290894BACKGROUND

MeSH Terms

Conditions

Sexual BehaviorInfertilityOrgasm

Condition Hierarchy (Ancestors)

BehaviorGenital DiseasesUrogenital Diseases

Study Officials

  • emine özge avcı

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 23, 2024

Study Start

November 26, 2022

Primary Completion

June 20, 2023

Study Completion

November 20, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations