Sexual ActivityNCT06515067
Effect of Back Massage on ınfertılıty Stress, Sexual satısfactıon and marrıage Harmony ın ınfertılıty Couples
A study testing back massage and no ıntervention in people with Sexual Activity and Infertility, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Activity, Infertility, Stress
- What is being tested?
- back massage and no ıntervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2022to 20 Nov 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Unable to communicate,
- Couples who do not want to participate in the research will not be included in the research.
- Those who have conditions that prevent massage (those with fever, wounds on their backs, individuals with tumors, the presence of an incomprehensible mass, those with orthopedic disorders, etc.) Exclusion Criteria for the Control Group
- Individuals who cannot be contacted and do not want to participate in the research will not be included in the research.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Infertility is defined as the inability to become pregnant despite regular, unprotected sexual intercourse for 12 months. Infertility can cause decreased sexual satisfaction, deterioration of marital harmony and separation in couples. Massage with contact and touch can increase harmony between couples, reduce stress and contribute to increased sexual satisfaction. This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples.
The couples included in the study were divided into two groups: study and control groups. All patients completed the demographic information scale, The COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale. Back massage was taught to the couples in the study group and the spouses were allowed to perform back massage during the infertility treatment. No intervention was applied in the control group. A month later, the COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale were repeated on the fences. Mann Whitney u test, ki kare test and wilxon test used to analyze data.
Marital harmony and sexual satisfaction were found to be higher and stress levels were lower in couples who received back massage.
As a result, it has been shown that back massage has positive effects on infertility stress, sexual satisfaction and marital harmony in infertile couples.
- Conditions
- Sexual Activity, Infertility, Stress
- Being tested
- back massage, no ıntervention
- Keywords
- infertility, back massage, sexual satisfaction
- Medical subject headings
- Sexual Behavior, Infertility, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
back massageOther
back massage
no ınterventionOther
no ıntervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | People in this group applied back massage Receives: Other: back massage |
| control group | Other | People in this group did not apply back massage Receives: Other: no ıntervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 Mounths
Secondary outcomes (1)
COMPI coping with infertility stress scale
The scale, developed to measure coping strategies with certain stressors related to infertility, consists of 19 items. In the scale, items 1 to 17 are evaluated on a 4-point Likert scale, and items 18 and 19 are evaluated on a 3-point scale.
Measured: 2 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start26 Nov 2022
- Primary completion20 Jun 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual ActivityStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Özge AVCI, TC Erciyes University
- Investigators
- emine özge avcı, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515067
- Sponsor's protocol ID
- 0000000
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33308486Alirezaei 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.
PubMed 29707928Aourell 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.
PubMed 16290894
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Back Massage on ınfertılıty Stress, Sexual satısfactıon and marrıage Harmony ın ınfertılıty Couples
- ClinicalTrials.gov ID
- NCT06515067
- Acronym / sponsor ID
- 0000000
- Conditions
- Sexual Activity, Infertility, Stress
- Keywords
- infertility, back massage, sexual satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 23 Jul 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 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.
Detailed description
Infertility is defined as the inability to become pregnant despite regular, unprotected sexual intercourse for 12 months. Infertility can cause decreased sexual satisfaction, deterioration of marital harmony and separation in couples. Massage with contact and touch can increase harmony between couples, reduce stress and contribute to increased sexual satisfaction. This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples.
The couples included in the study were divided into two groups: study and control groups. All patients completed the demographic information scale, The COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale. Back massage was taught to the couples in the study group and the spouses were allowed to perform back massage during the infertility treatment. No intervention was applied in the control group. A month later, the COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale were repeated on the fences. Mann Whitney u test, ki kare test and wilxon test used to analyze data.
Marital harmony and sexual satisfaction were found to be higher and stress levels were lower in couples who received back massage.
As a result, it has been shown that back massage has positive effects on infertility stress, sexual satisfaction and marital harmony in infertile couples.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: back massagePeople in this group applied back massage |
| control group | Other | Other: no ınterventionPeople in this group did not apply back massage |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- Unable to communicate,
- Couples who do not want to participate in the research will not be included in the research.
- Those who have conditions that prevent massage (those with fever, wounds on their backs, individuals with tumors, the presence of an incomprehensible mass, those with orthopedic disorders, etc.) Exclusion Criteria for the Control Group
- Individuals who cannot be contacted and do not want to participate in the research will not be included in the research.
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 |
|---|---|---|
| back massageback massage | Other | study group |
| no ınterventionno ıntervention | Other | control group |
Primary outcome
İnfertility stress scale for measuring infertility stres
Time frame: 2 mouths
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.
Marital Adjustment Scale
Time frame: 2 mounths
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.
Golumbuok Rust Sexual Satisfaction Scale
Time frame: 2 Mounths
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.
1 secondary outcome
COMPI coping with infertility stress scale
Time frame: 2 mouths
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 23 Jul 2024.
- Background: PubMed 33308486Agarwal 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.
- Background: PubMed 29707928Alirezaei 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.
- Background: PubMed 16290894Aourell 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.
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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.
emine özge avcı principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing back massage and no ıntervention in people with Sexual Activity and Infertility, run by TC Erciyes University 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 1 inclusion and 4 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 23 Jul 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?
İnfertility stress scale for measuring infertility stres (time frame: 2 mouths). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515067, which also lists 3 linked publications.
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 23 Jul 2024.