Chronic PainNCT07199647
Pain and Health Beliefs in Rehabilitation Outpatients
An observational study of Chronic Pain and Musculoskeletal Diseases, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study was conducted to investigate the relationships between patients' pain beliefs, health beliefs about complementary and alternative medicine, and levels of spiritual well-being in a Physical Medicine and Rehabilitation outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Diseases
- What is being tested?
- Questionnaire Administration
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2024to 30 Jun 2025
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 65 years who attended the Physical Medicine and Rehabilitation outpatient clinic of a university hospital in Türkiye.
Who may be able to join
- Adults between 18 and 65 years of age
- Attending the Physical Medicine and Rehabilitation outpatient clinic
- Able to read and write
- Cognitively intact
- Voluntarily willing to participate and able to provide informed consent
Who cannot join
- Younger than 18 years or older than 65 years
- Illiterate individuals
- Individuals with cognitive impairment
- Individuals with communication difficulties
- Patients who declined to participate or had incomplete data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100
About this study
Official title: Pain Beliefs, Spiritual Well-Being, and Health Beliefs on Complementary and Alternative Medicine in Rehabilitation Outpatients: A Cross-Sectional Study
This cross-sectional study was conducted to investigate the relationships between patients' pain beliefs, health beliefs about complementary and alternative medicine, and levels of spiritual well-being in a Physical Medicine and Rehabilitation outpatient clinic. Adult participants between 18 and 65 years of age were enrolled. Standardized questionnaires were used to evaluate psychological status, pain-related beliefs, attitudes toward complementary and alternative medicine, and spiritual well-being. The study aimed to contribute to holistic pain management approaches by integrating psychological, spiritual, and health belief perspectives.
Read the detailed description
Detailed Description:
This cross-sectional analytical study was designed to evaluate the interrelationships between pain beliefs, health beliefs regarding complementary and alternative medicine (CAM), and spiritual well-being in patients attending a Physical Medicine and Rehabilitation (PMR) outpatient clinic.
Rationale:
Chronic musculoskeletal pain is among the most frequent reasons for PMR admission. Prior research has examined pain beliefs, CAM utilization, or spirituality separately, yet little is known about their combined influence on patient coping, psychological status, and treatment orientation. Understanding these multidimensional factors is essential for advancing holistic, patient-centered rehabilitation strategies.
Study Design and Methods:
The study was conducted at Yozgat Bozok University, Faculty of Medicine, Department of PMR. A cross-sectional analytical design was employed. Eligible participants were adults aged 18-65 years who were literate, cognitively intact, and consented voluntarily. Exclusion criteria included communication or cognitive impairments, refusal to participate, or age outside the inclusion range.
Assessments:
Participants completed standardized, validated Turkish versions of the following instruments:
Hospital Anxiety and Depression Scale (HADS): evaluation of anxiety and depression symptoms.
Pain Beliefs Questionnaire (PBQ): assessment of organic and psychological pain beliefs.
Complementary, Alternative, and Conventional Medicine Attitude Scale (CACMAS): evaluation of attitudes toward CAM and conventional medicine.
Complementary and Alternative Medicine Health Belief Questionnaire (CHBQ): assessment of CAM-related health beliefs.
Three-Factor Spiritual Well-Being Scale (TFSWBS): measurement of transcendence, harmony with nature, and anomie.
Statistical Plan:
Descriptive statistics were calculated for demographic and clinical variables. Group comparisons were performed using Student's t-test, ANOVA, or chi-square tests, as appropriate. Correlation analyses explored associations among psychological, cognitive, and spiritual outcomes. Multiple regression models were applied to identify predictors of CAM health beliefs and spiritual well-being. Sample size was determined a priori using G*Power (version 3.1.9.7) to achieve 95% power with five predictors at α = 0.05.
Expected Contribution:
By integrating cognitive, psychological, and spiritual dimensions, the study seeks to clarify how pain beliefs and CAM health beliefs relate to spiritual well-being in rehabilitation patients. Findings are expected to support the incorporation of structured spiritual assessments and evidence-based CAM counseling into PMR practice to enhance holistic pain management.
- Conditions
- Chronic Pain, Musculoskeletal Diseases
- Being tested
- Questionnaire Administration
- Keywords
- Pain Beliefs, Spiritual Well-Being, Complementary and Alternative Medicine, Health Beliefs, Rehabilitation, Physical Medicine and Rehabilitation, Outpatients, Anxiety, Depression, Rehabilitation outpatients
- Medical subject headings
- Chronic Pain, Musculoskeletal Diseases, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Participants completed a sociodemographic questionnaire, the Hospital Anxiety and Depression Scale, the Pain Beliefs Questionnaire, the Complementary, Alternative, and Conventional Medicine Attitude Scale, the Complementary and Alternative Medicine Health Belief Scale, and the Three-Factor Spiritual Well-Being Scale.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Outpatients | Adult patients (18-65 years) attending a university hospital Physical Medicine and Rehabilitation outpatient clinic. Participants were evaluated once using self-report questionnaires and scales Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Beliefs Questionnaire
Description: The Pain Beliefs Questionnaire was developed in 1992 by Edwards and colleagues. It contains 12 items. Six items assess organic pain beliefs (score range: 6-30) and four items assess psychological pain beliefs (score range: 4-20). Participants rate each item using a Likert-type scale from 1 to 5. Higher scores on the organic subscale indicate stronger beliefs in an organic cause of pain (considered maladaptive), while higher scores on the psychological subscale indicate stronger beliefs in a psychological origin of pain (considered more adaptive).
Measured: At enrollment
Three-Factor Spiritual Well-Being Scale
Description: The Three-Factor Spiritual Well-Being Scale was developed in 2017 by Eksi and Kardas. It contains 29 items with three subscales: transcendence (11 items, score range: 11-55), harmony with nature (6 items, score range: 6-30), and anomie (12 items, score range: 12-60; reverse-scored). Items are rated on a 5-point Likert scale. The total score ranges from 29 to 145. Higher total scores indicate greater levels of spiritual well-being (a better outcome).
Measured: At enrollment
Complementary and Alternative Medicine Health Belief Scale
This scale was developed in 2004 by Lie and Boker. It contains 10 items. Each item is scored on a seven-point Likert scale. Three of the items are reverse-scored. The total score ranges from 10 to 70. Higher scores indicate stronger health beliefs related to complementary and alternative medicine. The scale does not have a cut-off score.
Measured: At enrollment
Secondary outcomes (2)
Hospital Anxiety and Depression Scale
This scale was developed in 1983 by Zigmond and Snaith. It contains 14 items. Seven items measure anxiety and seven items measure depression. Each item is scored on a scale from 0 to 3. Some items are reverse-scored. The cut-off score is 10 for anxiety and 7 for depression. Higher scores indicate higher levels of anxiety or depression. The scale does not provide a total score but gives separate scores for the two subscales.
Measured: At enrollment
Complementary, Alternative, and Conventional Medicine Attitude Scale
This scale was developed in 2010 by McFadden and colleagues. It contains 25 items. It has three subscales: attitudes toward complementary and alternative medicine, dissatisfaction with conventional medicine, and holistic balance. Participants rate each item using a Likert-type scale. The scale does not have a cut-off score. Higher scores indicate a more favorable attitude toward complementary and alternative medicine and stronger belief in holistic balance.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start19 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 116 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulseren Demir Karakilic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulseren Demir Karakilic, Bozok University
- Investigators
- Gülseren Demir Karakılıç, Asst Prof, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199647
- Sponsor's protocol ID
- 2024-GOKAEK-2415_2024.12.18_29
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. De-identified data will be shared for academic and research purposes in accordance with institutional and ethical guidelines.
Publications
Uslu, F. (2020). Geleneksel ve tamamlayıcı tıp (getat) sağlık inanış anketinin türkçe geçerlilik ve güvenilirlik çalışması. (Uzmanlık Tezi). Sağlık Bilimleri Üniversitesi Ankara Dışkapı Yıldırım Beyazıt Sağlık Uygulama ve Araştırma Merkezi Aile Hekimliği Kliniği, Ankara. https://tez.yok.gov.tr/UlusalTezMerkezi/ sayfasından erişilmiştir. (Tez Numarası 644233).
Elif, K. Ö. S. E., Hasan Çetin Ekerbiçer, and Ünal Erkorkmaz. "Complementary, alternative and conventional medicine attitude scale: Turkish validity reliability study." Sakarya Tıp Dergisi 8.4 (2018): 726-736.
Hyland ME, Lewith GT, Westoby C. Developing a measure of attitudes: the holistic complementary and alternative medicine questionnaire. Complement Ther Med. 2003 Mar;11(1):33-8. doi: 10.1016/s0965-2299(02)00113-9.
PubMed 12667973Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.
PubMed 1491853Aydemir, O. J. T. P. D: Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirliği. Türk Psikiyatri Dergisi, 8, 187-280, 1997.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Okan N, Kose N, Kardas S. Spiritual Contradiction Scale: A New Way of Understanding Internal and External Contradictions. J Relig Health. 2024 Apr;63(2):1567-1584. doi: 10.1007/s10943-023-01924-2. Epub 2023 Oct 11.
PubMed 37819529Berk HO, Bahadir G. [The experience of chronic pain and pain beliefs]. Agri. 2007 Oct;19(4):5-15. Turkish.
PubMed 18159574
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Beliefs, Spiritual Well-Being, and Health Beliefs on Complementary and Alternative Medicine in Rehabilitation Outpatients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07199647
- Acronym / sponsor ID
- 2024-GOKAEK-2415_2024.12.18_29
- Conditions
- Chronic Pain, Musculoskeletal Diseases
- Keywords
- Pain Beliefs, Spiritual Well-Being, Complementary and Alternative Medicine, Health Beliefs, Rehabilitation, Physical Medicine and Rehabilitation, Outpatients, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Gulseren Demir KarakilicUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Sep 2025 (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.
This cross-sectional study was conducted to investigate the relationships between patients' pain beliefs, health beliefs about complementary and alternative medicine, and levels of spiritual well-being in a Physical Medicine and Rehabilitation outpatient clinic. Adult participants between 18 and 65 years of age were enrolled. Standardized questionnaires were used to evaluate psychological status, pain-related beliefs, attitudes toward complementary and alternative medicine, and spiritual well-being. The study aimed to contribute to holistic pain management approaches by integrating psychological, spiritual, and health belief perspectives.
Detailed description
Detailed Description:
This cross-sectional analytical study was designed to evaluate the interrelationships between pain beliefs, health beliefs regarding complementary and alternative medicine (CAM), and spiritual well-being in patients attending a Physical Medicine and Rehabilitation (PMR) outpatient clinic.
Rationale:
Chronic musculoskeletal pain is among the most frequent reasons for PMR admission. Prior research has examined pain beliefs, CAM utilization, or spirituality separately, yet little is known about their combined influence on patient coping, psychological status, and treatment orientation. Understanding these multidimensional factors is essential for advancing holistic, patient-centered rehabilitation strategies.
Study Design and Methods:
The study was conducted at Yozgat Bozok University, Faculty of Medicine, Department of PMR. A cross-sectional analytical design was employed. Eligible participants were adults aged 18-65 years who were literate, cognitively intact, and consented voluntarily. Exclusion criteria included communication or cognitive impairments, refusal to participate, or age outside the inclusion range.
Assessments:
Participants completed standardized, validated Turkish versions of the following instruments:
Hospital Anxiety and Depression Scale (HADS): evaluation of anxiety and depression symptoms.
Pain Beliefs Questionnaire (PBQ): assessment of organic and psychological pain beliefs.
Complementary, Alternative, and Conventional Medicine Attitude Scale (CACMAS): evaluation of attitudes toward CAM and conventional medicine.
Complementary and Alternative Medicine Health Belief Questionnaire (CHBQ): assessment of CAM-related health beliefs.
Three-Factor Spiritual Well-Being Scale (TFSWBS): measurement of transcendence, harmony with nature, and anomie.
Statistical Plan:
Descriptive statistics were calculated for demographic and clinical variables. Group comparisons were performed using Student's t-test, ANOVA, or chi-square tests, as appropriate. Correlation analyses explored associations among psychological, cognitive, and spiritual outcomes. Multiple regression models were applied to identify predictors of CAM health beliefs and spiritual well-being. Sample size was determined a priori using G*Power (version 3.1.9.7) to achieve 95% power with five predictors at α = 0.05.
Expected Contribution:
By integrating cognitive, psychological, and spiritual dimensions, the study seeks to clarify how pain beliefs and CAM health beliefs relate to spiritual well-being in rehabilitation patients. Findings are expected to support the incorporation of structured spiritual assessments and evidence-based CAM counseling into PMR practice to enhance holistic pain management.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Outpatients | – | Other: Questionnaire AdministrationAdult patients (18-65 years) attending a university hospital Physical Medicine and Rehabilitation outpatient clinic. Participants were evaluated once using self-report questionnaires and scales |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 65 years who attended the Physical Medicine and Rehabilitation outpatient clinic of a university hospital in Türkiye.
Key inclusion criteria (5 listed)
- Adults between 18 and 65 years of age
- Attending the Physical Medicine and Rehabilitation outpatient clinic
- Able to read and write
- Cognitively intact
- Voluntarily willing to participate and able to provide informed consent
Key exclusion criteria (5 listed)
- Younger than 18 years or older than 65 years
- Illiterate individuals
- Individuals with cognitive impairment
- Individuals with communication difficulties
- Patients who declined to participate or had incomplete data
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 |
|---|---|---|
| Questionnaire AdministrationParticipants completed a sociodemographic questionnaire, the Hospital Anxiety and Depression Scale, the Pain Beliefs Questionnaire, the Complementary, Alternative, and Conventional Medicine Attitude Scale, the Complementary and Alternative Medicine Health Belief Scale, and the Three-Factor Spiritual Well-Being Scale. | Other | Rehabilitation Outpatients |
Primary outcome
Pain Beliefs Questionnaire
Time frame: At enrollment
Description: The Pain Beliefs Questionnaire was developed in 1992 by Edwards and colleagues. It contains 12 items. Six items assess organic pain beliefs (score range: 6-30) and four items assess psychological pain beliefs (score range: 4-20). Participants rate each item using a Likert-type scale from 1 to 5. Higher scores on the organic subscale indicate stronger beliefs in an organic cause of pain (considered maladaptive), while higher scores on the psychological subscale indicate stronger beliefs in a psychological origin of pain (considered more adaptive).
Three-Factor Spiritual Well-Being Scale
Time frame: At enrollment
Description: The Three-Factor Spiritual Well-Being Scale was developed in 2017 by Eksi and Kardas. It contains 29 items with three subscales: transcendence (11 items, score range: 11-55), harmony with nature (6 items, score range: 6-30), and anomie (12 items, score range: 12-60; reverse-scored). Items are rated on a 5-point Likert scale. The total score ranges from 29 to 145. Higher total scores indicate greater levels of spiritual well-being (a better outcome).
Complementary and Alternative Medicine Health Belief Scale
Time frame: At enrollment
This scale was developed in 2004 by Lie and Boker. It contains 10 items. Each item is scored on a seven-point Likert scale. Three of the items are reverse-scored. The total score ranges from 10 to 70. Higher scores indicate stronger health beliefs related to complementary and alternative medicine. The scale does not have a cut-off score.
2 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: At enrollment
Complementary, Alternative, and Conventional Medicine Attitude Scale
Time frame: At enrollment
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 3 Oct 2025.
- BackgroundUslu, F. (2020). Geleneksel ve tamamlayıcı tıp (getat) sağlık inanış anketinin türkçe geçerlilik ve güvenilirlik çalışması. (Uzmanlık Tezi). Sağlık Bilimleri Üniversitesi Ankara Dışkapı Yıldırım Beyazıt Sağlık Uygulama ve Araştırma Merkezi Aile Hekimliği Kliniği, Ankara. https://tez.yok.gov.tr/UlusalTezMerkezi/ sayfasından erişilmiştir. (Tez Numarası 644233).
- BackgroundElif, K. Ö. S. E., Hasan Çetin Ekerbiçer, and Ünal Erkorkmaz. "Complementary, alternative and conventional medicine attitude scale: Turkish validity reliability study." Sakarya Tıp Dergisi 8.4 (2018): 726-736.
- Background: PubMed 12667973Hyland ME, Lewith GT, Westoby C. Developing a measure of attitudes: the holistic complementary and alternative medicine questionnaire. Complement Ther Med. 2003 Mar;11(1):33-8. doi: 10.1016/s0965-2299(02)00113-9.
- Background: PubMed 1491853Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.
- BackgroundAydemir, O. J. T. P. D: Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirliği. Türk Psikiyatri Dergisi, 8, 187-280, 1997.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 37819529Okan N, Kose N, Kardas S. Spiritual Contradiction Scale: A New Way of Understanding Internal and External Contradictions. J Relig Health. 2024 Apr;63(2):1567-1584. doi: 10.1007/s10943-023-01924-2. Epub 2023 Oct 11.
- Background: PubMed 18159574Berk HO, Bahadir G. [The experience of chronic pain and pain beliefs]. Agri. 2007 Oct;19(4):5-15. Turkish.
- Individual participant dataSharing planned: Yes. The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. De-identified data will be shared for academic and research purposes in accordance with institutional and ethical guidelines.
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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.
Gülseren Demir Karakılıç, Asst Prof principal investigator
Yozgat Bozok University
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 Chronic Pain and Musculoskeletal Diseases, run by Gulseren Demir Karakilic 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 5 inclusion and 5 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 3 Oct 2025. 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?
Pain Beliefs Questionnaire (time frame: At enrollment). 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 NCT07199647, which also lists 8 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 3 Oct 2025.