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NCT Number: NCT07536672

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.

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Key information

Conditions

Fibromyalgia Back Pain Back Pain Lower Back Chronic Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neck Pain Neck Pain Musculoskeletal Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kütahya Health Sciences University, Kütahya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surveys

Other

Similar surveys will be administered to both groups.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. IIEF-5

    Time frame: DAY 1

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

SEXUAL FUNCTIONALITY IN CHRONIC PRIMARY PAIN CONDITIONS: VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE

Acronym: SPQ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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