NCT07536672

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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 Progress53%
Oct 2025Nov 2026

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

April 17, 2026

Status Verified

October 1, 2025

Enrollment Period

8 months

First QC Date

April 6, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

Sex painfibromyaljianeck painback painmusculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • 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).

    DAY 1

Secondary Outcomes (3)

  • YCDÖ

    DAY 1

  • FSFI-6

    DAY 1

  • IIEF-5

    DAY 1

Study Arms (2)

musculuskeletal pain

healthy individuals

Other: surveys

healthy individuals

without primary musculoskeletal pain

Other: surveys

Interventions

surveysOTHER

Similar surveys will be administered to both groups.

healthy individualsmusculuskeletal pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary musculuskeletal pain, healthy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kütahya Health Sciences University

Kütahya, Kütahya, 43020, Turkey (Türkiye)

Location

Kütahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaMusculoskeletal DiseasesNeck PainBack PainMusculoskeletal Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Muscular DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 17, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

April 17, 2026

Record last verified: 2025-10

Locations