FibromyalgiaSPQNCT07536672
VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE
An observational study of Fibromyalgia and Neck Pain Musculoskeletal, run by Kutahya Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
Although there are many questionnaires used in the literature regarding sexual function and satisfaction, these questionnaires evaluate sexual problems regardless of the chronic pain condition and have not been validated for chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Neck Pain Musculoskeletal, Back Pain Lower Back Chronic
- What is being tested?
- surveys
- How many people
- 170 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 20 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary musculuskeletal pain, healthy
Who may be able to join
- patient with primary chronic pain (such as non-specific lower back/neck pain, fibromyalgia)
- pain lasting longer than 3 months (as classified by IASP in 2019),
- who has been in a regular and stable heterosexual relationship for the past year.
Who cannot join
- who have not had a regular and stable heterosexual relationship for the last year
- have serious and secondary musculoskeletal diseases
- have post-surgical and post-traumatic pain
- have underlying pathological causes such as chronic neuropathic pain, visceral pain
- with severe cognitive impairment
- who have difficulty understanding and completing the items in the questionnaire will be excluded from the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Kütahya Health Sciences University
Kütahya, Kütahya, 43020
Kütahya Health Sciences University
Kütahya, 43020
About this study
Official title: SEXUAL FUNCTIONALITY IN CHRONIC PRIMARY PAIN CONDITIONS: VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE
Although there are many questionnaires used in the literature regarding sexual function and satisfaction, these questionnaires evaluate sexual problems regardless of the chronic pain condition and have not been validated for chronic pain. It has been reported that developing a standard or consensus-determined measure to evaluate sexual health in musculoskeletal pain would be advantageous for clinical practice and research. For this purpose, the only study we encountered in the literature is the Sexual Functionality in Chronic Primary Pain Conditions: Sex Pain Questionnaire developed by Rafael Ballester-Arnal in 2022. The questionnaire, consisting of 17 items, comprises two factors: "Sexual and relationship dissatisfaction" and "The effect of chronic pain on sexual life" and has good psychometric properties (Internal consistency indices of 0.72 and 0.96). This study was planned to establish the Turkish validity and reliability of the Sexual Functionality in Chronic Primary Pain Conditions: Sex Pain Questionnaire, which was developed to identify sexual function problems that are impaired due to physical pain in patients with chronic pain, and to contribute it to the literature.
Read the detailed description
Developing goal-oriented and appropriate prevention and management strategies is crucial in coping with chronic pain. Therefore, all factors associated with chronic pain, including biological, psychological, socio-demographic, and lifestyle determinants, their consequences, and follow-up should be investigated.
Sexual and relationship health are also important components of quality of life ( Studies in the literature show that sexual function and relationships are negatively affected in chronic pain conditions compared to healthy controls. It is reported that sexual function and relationships are negatively affected, especially in women, as pain intensity, anxiety, depression, stress, fear avoidance, and catastrophizing increase, physical function decreases, body image distortion and self-efficacy perception decrease, and psychosocial problems are present. However, despite its importance for patients, many clinicians do not address sexual health issues due to lack of time, resources, and training, concerns about knowledge and skills, fear of criminality, personal discomfort, and lack of awareness about potential sexual health problems in patient groups.
- Conditions
- Fibromyalgia, Neck Pain Musculoskeletal, Back Pain Lower Back Chronic, Musculoskeletal Diseases
- Being tested
- surveys
- Keywords
- Sex pain, fibromyaljia, neck pain, back pain, musculoskeletal pain
- Medical subject headings
- Fibromyalgia, Musculoskeletal Diseases, Neck Pain, Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveysOther
Similar surveys will be administered to both groups.
| Study group | Role | What they receive |
|---|---|---|
| musculuskeletal pain | healthy individuals Receives: Other: surveys | |
| healthy individuals | without primary musculoskeletal pain Receives: Other: surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPQ
The Sexual Functionality in Chronic Primary Pain Conditions: Pain of Sex Questionnaire was developed by Rafael Ballester-Arnal et al. in 2022. The 17-item questionnaire consists of two factors: "Sexual and relationship dissatisfaction" and "The impact of chronic pain on sexual life," and has good psychometric properties (internal consistency indices of 0.72 and 0.96).
Measured: DAY 1
Secondary outcomes (3)
YCDÖ
To assess sexual satisfaction, the Turkish version of the New Sexual Satisfaction Scale, which has been validated and proven reliable, will be used. The original's total score reliability coefficient was found to be r=0.57-0.61 and its internal consistency coefficient was 0.94. The questionnaire, consisting of 20 items, is composed of two sub-dimensions: egocentric and partner/sexual activity-centric, and is answered using a 5-point Likert scale (1: not satisfied at all, 2: somewhat satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied). The scale score is calculated by summing the items, and the possible score is between 20 and 100. A high score on the scale indicates good sexual satisfaction.
Measured: DAY 1
FSFI-6
The 6-item version, developed from the 19-item version that assesses sexual dysfunction in women, and whose Turkish validity and reliability have been established, will be used the questionnaire includes questions on desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual function, reflecting the main categories of sexual dysfunction as described in the International Classification of Diseases (ICD-10). The questionnaire is evaluated using a 5-point Likert scale and is scored between 2 and 36. A lower score indicates an increase in the severity of the dysfunction. The cutoff score is 19.
Measured: DAY 1
IIEF-5
The Turkish version with 5 items, developed from the 15-item version (18) that assesses sexual function in men, will be used. The questionnaire includes questions that inquire about sexual function, erectile function, orgasm function, sexual desire, sexual intercourse satisfaction, and general satisfaction. The questionnaire is evaluated using a 5-point Likert scale (1: very low, 2: low, 3: average, 4: high, 5: very high) and is scored between 5 and 25. A decrease in the score indicates an increase in the severity of erectile dysfunction. The cutoff score for the questionnaire is 21.
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Oct 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Tamer, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536672
- Sponsor's protocol ID
- KHSU-ST-03
- Acronym
- SPQ
- Status last verified
- Oct 2025
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only when requested by authorized persons
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEXUAL FUNCTIONALITY IN CHRONIC PRIMARY PAIN CONDITIONS: VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE
- ClinicalTrials.gov ID
- NCT07536672
- Acronym / sponsor ID
- SPQ / KHSU-ST-03
- Conditions
- Fibromyalgia, Neck Pain Musculoskeletal, Back Pain Lower Back Chronic, Musculoskeletal Diseases
- Keywords
- Sex pain, fibromyaljia, neck pain, back pain, musculoskeletal pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 17 Apr 2026 (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.
Although there are many questionnaires used in the literature regarding sexual function and satisfaction, these questionnaires evaluate sexual problems regardless of the chronic pain condition and have not been validated for chronic pain. It has been reported that developing a standard or consensus-determined measure to evaluate sexual health in musculoskeletal pain would be advantageous for clinical practice and research. For this purpose, the only study we encountered in the literature is the Sexual Functionality in Chronic Primary Pain Conditions: Sex Pain Questionnaire developed by Rafael Ballester-Arnal in 2022. The questionnaire, consisting of 17 items, comprises two factors: "Sexual and relationship dissatisfaction" and "The effect of chronic pain on sexual life" and has good psychometric properties (Internal consistency indices of 0.72 and 0.96). This study was planned to establish the Turkish validity and reliability of the Sexual Functionality in Chronic Primary Pain Conditions: Sex Pain Questionnaire, which was developed to identify sexual function problems that are impaired due to physical pain in patients with chronic pain, and to contribute it to the literature.
Detailed description
Developing goal-oriented and appropriate prevention and management strategies is crucial in coping with chronic pain. Therefore, all factors associated with chronic pain, including biological, psychological, socio-demographic, and lifestyle determinants, their consequences, and follow-up should be investigated.
Sexual and relationship health are also important components of quality of life ( Studies in the literature show that sexual function and relationships are negatively affected in chronic pain conditions compared to healthy controls. It is reported that sexual function and relationships are negatively affected, especially in women, as pain intensity, anxiety, depression, stress, fear avoidance, and catastrophizing increase, physical function decreases, body image distortion and self-efficacy perception decrease, and psychosocial problems are present. However, despite its importance for patients, many clinicians do not address sexual health issues due to lack of time, resources, and training, concerns about knowledge and skills, fear of criminality, personal discomfort, and lack of awareness about potential sexual health problems in patient groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| musculuskeletal pain | – | Other: surveyshealthy individuals |
| healthy individuals | – | Other: surveyswithout primary musculoskeletal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary musculuskeletal pain, healthy
Key inclusion criteria (3 listed)
- patient with primary chronic pain (such as non-specific lower back/neck pain, fibromyalgia)
- pain lasting longer than 3 months (as classified by IASP in 2019),
- who has been in a regular and stable heterosexual relationship for the past year.
Key exclusion criteria (6 listed)
- who have not had a regular and stable heterosexual relationship for the last year
- have serious and secondary musculoskeletal diseases
- have post-surgical and post-traumatic pain
- have underlying pathological causes such as chronic neuropathic pain, visceral pain
- with severe cognitive impairment
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 |
|---|---|---|
| surveysSimilar surveys will be administered to both groups. | Other | healthy individuals, musculuskeletal pain |
Primary outcome
SPQ
Time frame: DAY 1
The Sexual Functionality in Chronic Primary Pain Conditions: Pain of Sex Questionnaire was developed by Rafael Ballester-Arnal et al. in 2022. The 17-item questionnaire consists of two factors: "Sexual and relationship dissatisfaction" and "The impact of chronic pain on sexual life," and has good psychometric properties (internal consistency indices of 0.72 and 0.96).
3 secondary outcomes
YCDÖ
Time frame: DAY 1
FSFI-6
Time frame: DAY 1
IIEF-5
Time frame: DAY 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided. only when requested by authorized persons
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Neck Pain Musculoskeletal, run by Kutahya Health Sciences University at 2 sites 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 3 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
SPQ (time frame: DAY 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.