FibromyalgiaNCT05915403
Frequency of Sexual Intercourse,Women With Fibromyalgia
An observational study of Fibromyalgia and Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia? Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Pain, Depression
- What is being tested?
- Fibromyalgia Impact Questionnaire
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Feb 2023
- Phase
- Observational
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: tertiary healthcare facility
Who may be able to join
- Female patient with fibromyalgia
Who cannot join
- Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),
- Major psychiatric disease,
- Endocrine disease,
- Pregnancy
- Menopausal status,
- Antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
About this study
Official title: The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia
Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?
- Conditions
- Fibromyalgia, Pain, Depression
- Being tested
- Fibromyalgia Impact Questionnaire
- Medical subject headings
- Fibromyalgia, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia Impact QuestionnaireDiagnostic test
Also called Visual Analog Scale, Beck Depression Inventory, Widespread Pain Index, Symptom Severity Scale
diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Patient | female patient with fibromyalgia Receives: Diagnostic Test: Fibromyalgia Impact Questionnaire | |
| healthy controls | women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
pain level 0-10, higher scores indicate worse outcome
Measured: 1 week
frequency of sexual intercourse
mean monthly frequency of sexual intercourse in the last 3 months
Measured: 3 mounths
Fibromyalgia Impact Questionnaire
0-80, higher scores indicate worse outcome
Measured: 1 week
Secondary outcomes (3)
Beck Depression Inventory
0-63, higher scores indicate worse outcome
Measured: 1 week
Widespread Pain Index
0-19, higher scores indicate worse outcome
Measured: 1 week
Symptom Severity Scale
0-12, higher scores indicate worse outcome
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915403
- Sponsor's protocol ID
- 2021-01-05
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maunder L, Schoemaker D, Pruessner JC. Frequency of Penile-Vaginal Intercourse is Associated with Verbal Recognition Performance in Adult Women. Arch Sex Behav. 2017 Feb;46(2):441-453. doi: 10.1007/s10508-016-0890-4. Epub 2016 Nov 14.
PubMed 27844312Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Invest. 1999;47(2):125-6. doi: 10.1159/000010075.
PubMed 9949283Burleson MH, Trevathan WR, Todd M. In the mood for love or vice versa? Exploring the relations among sexual activity, physical affection, affect, and stress in the daily lives of mid-aged women. Arch Sex Behav. 2007 Jun;36(3):357-68. doi: 10.1007/s10508-006-9071-1.
PubMed 17109236Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
PubMed 21681120
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frequency of Sexual Intercourse on Symptoms in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05915403
- Acronym / sponsor ID
- 2021-01-05
- Conditions
- Fibromyalgia, Pain, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Jun 2023 (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.
Does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Diagnostic Test: Fibromyalgia Impact Questionnairefemale patient with fibromyalgia |
| healthy controls | – | –women |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- tertiary healthcare facility
Key inclusion criteria (1 listed)
- Female patient with fibromyalgia
Key exclusion criteria (6 listed)
- Uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological),
- Major psychiatric disease,
- Endocrine disease,
- Pregnancy
- Menopausal status,
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 |
|---|---|---|
| Fibromyalgia Impact QuestionnaireAlso: Visual Analog Scale, Beck Depression Inventory, Widespread Pain Index, Symptom Severity Scalediagnostic tests | Diagnostic test | Patient |
Primary outcome
Visual Analog Scale
Time frame: 1 week
pain level 0-10, higher scores indicate worse outcome
frequency of sexual intercourse
Time frame: 3 mounths
mean monthly frequency of sexual intercourse in the last 3 months
Fibromyalgia Impact Questionnaire
Time frame: 1 week
0-80, higher scores indicate worse outcome
3 secondary outcomes
Beck Depression Inventory
Time frame: 1 week
Widespread Pain Index
Time frame: 1 week
Symptom Severity Scale
Time frame: 1 week
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 Jun 2023.
- Results publication: PubMed 27844312Maunder L, Schoemaker D, Pruessner JC. Frequency of Penile-Vaginal Intercourse is Associated with Verbal Recognition Performance in Adult Women. Arch Sex Behav. 2017 Feb;46(2):441-453. doi: 10.1007/s10508-016-0890-4. Epub 2016 Nov 14.
- Results publication: PubMed 9949283Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Invest. 1999;47(2):125-6. doi: 10.1159/000010075.
- Results publication: PubMed 17109236Burleson MH, Trevathan WR, Todd M. In the mood for love or vice versa? Exploring the relations among sexual activity, physical affection, affect, and stress in the daily lives of mid-aged women. Arch Sex Behav. 2007 Jun;36(3):357-68. doi: 10.1007/s10508-006-9071-1.
- Results publication: PubMed 21681120Ainsworth BE, Haskell WL, Herrmann SD, Meckes N, Bassett DR Jr, Tudor-Locke C, Greer JL, Vezina J, Whitt-Glover MC, Leon AS. 2011 Compendium of Physical Activities: a second update of codes and MET values. Med Sci Sports Exerc. 2011 Aug;43(8):1575-81. doi: 10.1249/MSS.0b013e31821ece12.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Fibromyalgia and Pain, run by Konya Beyhekim Training and Research Hospital 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 6 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 Jun 2023. 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?
Visual Analog Scale (time frame: 1 week). 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 NCT05915403, which also lists 4 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 Jun 2023.