- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536672
VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE (SPQ)
SEXUAL FUNCTIONALITY IN CHRONIC PRIMARY PAIN CONDITIONS: VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Kütahya, Turkey (Türkiye), 43020
- Kutahya Health Sciences University
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Kütahya
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Kütahya, Kütahya, Turkey (Türkiye), 43020
- Kutahya Health Sciences University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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musculuskeletal pain
healthy individuals
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Similar surveys will be administered to both groups.
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healthy individuals
without primary musculoskeletal pain
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Similar surveys will be administered to both groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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SPQ
Time Frame: DAY 1
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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).
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DAY 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
YCDÖ
Time Frame: DAY 1
|
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.
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DAY 1
|
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FSFI-6
Time Frame: DAY 1
|
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.
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DAY 1
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IIEF-5
Time Frame: DAY 1
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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.
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DAY 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Rheumatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Back Pain
- Musculoskeletal Pain
- Fibromyalgia
- Musculoskeletal Diseases
- Neck Pain
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- KHSU-ST-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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