FibromyalgiaFSRRFDNCT06777667
Fibromyalgia Severity: Role of Resilience and Family Dynamics
An observational study of Fibromyalgia and Resilience, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional survey study aims to examine the resilience and family dynamics between newly diagnosed fibromyalgia (FM) patients and healthy individuals. The study will analyze demographic data including parental attitude and childhood trauma and resilience levels using the Connor-Davidson Resilience Scale… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Resilience
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2024to 1 Mar 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will include adult females aged 25-45 years. Participants will be divided into two groups: (1) individuals with a diagnosis of fibromyalgia and (2) healthy female controls within the same age range. All participants will be recruited through convenience sampling, such as patients visiting the Physical Medicine and Rehabilitation Clinic at Antalya City Hospital, and will provide written informed consent.
Who may be able to join
- Age range: Women between the ages of 25-45.
- Diagnosis: For fibromyalgia Group: Individuals diagnosed according to the 2016 revision of the American College of Rheumatology's 2010/2011 fibromyalgia diagnostic criteria. For healthy Control Group: Healthy women without a fibromyalgia diagnosis.
- Consent: Individuals who volunteered to participate in the research processes and gave informed consent regarding the details of participation and signed the consent form.
Who cannot join
- Serious medical conditions: Individuals with serious health problems such as autoimmune diseases, cancer, severe heart and lung diseases, or acute pain caused by trauma, surgery, inflammatory joint diseases, etc.
- Psychiatric conditions: Individuals with psychiatric diseases, medication use, or whose mental state may affect their ability to understand and complete the survey questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Resilience and Family Dynamics on Disease Severity in Women With Fibromyalgia: Comparison With Healthy Controls
This cross-sectional survey study aims to examine the resilience and family dynamics between newly diagnosed fibromyalgia (FM) patients and healthy individuals. The study will analyze demographic data including parental attitude and childhood trauma and resilience levels using the Connor-Davidson Resilience Scale (CD-RISC-10) in fibromyalgia patients and healthy controls. The Revised Fibromyalgia Impact Questionnaire (FIQR) will also be administered to FM patients to determine the total impact and severity of the disease (mild, moderate, severe, very severe). In addition to aiming to reveal how FM patients compare to healthy individuals in terms of resilience and parental attitude, this study will also examine the relationship between disease severity and these psychosocial variables. As a result, the data obtained are expected to reveal both potential differences in resilience and family problems in FM patients and the relationship of these factors with disease severity.
Read the detailed description
FM is a common disease worldwide, characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is estimated that symptoms are seen in around 2-4% of the population. Although FM is due to a complex disease model triggered by biological and psychosocial variables, the details are still unclear.
While psychological resilience plays a critical role in coping with stress and chronic pain, a supportive family environment can contribute to individuals developing effective coping mechanisms. Research shows that low resilience levels can trigger FM and a controlling family environment can negatively affect emotional functioning.
The increase in the incidence of FM in recent years has placed additional burdens on the healthcare system. Therefore, it is necessary to provide new perspectives that will guide clinicians who face FM and contribute to improving treatment processes.
The research aims to develop a deep understanding of the etiology and course of FM, as well as to contribute to customizing individual treatment approaches and health services by revealing the effects of psychosocial factors. This study will contribute to the understanding of the relationships between psychological resilience, family dynamics and disease severity in fibromyalgia patients. The data to be obtained will help develop new perspectives and suggestions for clinical practices by emphasizing the importance of psychological support and family dynamics in the treatment processes of fibromyalgia. In addition, comparisons with healthy controls may lead to a better understanding of the needs of individuals with FM. Another important benefit expected from the study is to place more emphasis on the importance of resilience and problems in child development. These studies have the potential to reduce the risks of developing FM and similar diseases in tomorrow's adults. In this context, primary prevention strategies may contribute to public health and the burden on the health system.
This study aims to examine the relationships between psychological resilience, childhood problems and severity of fibromyalgia symptoms between FM patients and healthy control groups. In particular, it was aimed to determine which elements significantly affect symptom severity by evaluating the effects of these factors on FM.
The hypotheses of the study:
Hypothesis 1: Individuals with low psychological resilience and a negative parental attitude during childhood will experience more severe FM symptoms.
Hypothesis 2: FM patients will have lower psychological resilience and more negative parental attitude compared to healthy controls.
Rationale for the study:
FM is a common disease characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is characterized by chronic widespread pain, somatic symptoms, and cognitive difficulties. FM is seen in all populations worldwide, and the prevalence of symptoms varies between 2% and 4% in the general population. A model has been proposed for the pathogenesis of FM in which biological and psychosocial variables influence the susceptibility, triggering, and worsening of a chronic disease, but the details are unclear.
FM is a complex and multifactorial disorder, and the severity of its symptoms may be affected by the individual's psychosocial circumstances. While psychological resilience plays a critical role in coping with chronic pain and stress, a supportive family environment may encourage individuals to develop effective coping mechanisms. There may be a link between FM and resilience, as resilience is closely related to an individual's response to acute or chronic stress, which can affect chronic pain conditions such as FM. Resilience is a complex structure that is contributed by genetics and environmental factors, and in some individuals, these factors may help to develop a personality that is more resilient to stressful life events. Therefore, low resilience may be a trigger for FM. The family environment may also be a factor contributing to the complex structure of fibromyalgia. Previous research has found that a controlling (highly regimented and less independent) family environment in early adolescence is a key factor predicting poorer long-term emotional functioning in juvenile FM patients. Reports indicate that the incidence of fibromyalgia increased from 2001 to 2013, suggesting that the healthcare system will be further burdened by the management of this disease. This study will provide important guidance for clinicians facing FM and will help to provide new perspectives on the management of the disease.
This study aims to better understand the potential contributions and effects of these factors on the health of individuals by examining the effects of psychological resilience and family environment on the severity of fibromyalgia. The findings to be obtained in these areas may contribute to the development of individual treatment approaches and the customization of health services.
This study will provide data that can help improve treatment processes by developing a deeper understanding of the etiology and course of FM. In addition, understanding the role of psychosocial and environmental factors will allow the development of more targeted interventions for clinical practice.
- Conditions
- Fibromyalgia, Resilience
- Keywords
- Fibromyalgia, Connor-Davidson Resilience Scale
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia group | Individuals diagnosed with fibromyalgia according to the 2016 ACR criteria. Participants will be recruited from the Physical Medicine and Rehabilitation Clinic at Antalya City Hospital. Inclusion Criteria: Female, aged 25-45 years Diagnosis of fibromyalgia according to the 2016 revision of 2010/2011 ACR criteria Able to provide informed consent | |
| Healthy control group | Age- and sex-matched healthy female individuals. No diagnosis of fibromyalgia or any other chronic pain condition. Recruited from the community or other appropriate sources. Inclusion Criteria: * Female, aged 25-45 years * No history of fibromyalgia or other chronic pain conditions * Able to provide informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience levels
Comparison of resilience scores between fibromyalgia patients and healthy controls. (Resilience was measured using the 10-item Connor Davidson- Resilience Scale, which ranges from 0 to 40, with higher scores reflecting greater resilience and better psychological adaptability.)
Measured: Baseline/ at the time of enrollment
Secondary outcomes (1)
Correlation between resilience and the severity of fibromyalgia symptoms.
Resilience scores in relation to the severity of fibromyalgia symptoms. (Severity of fibromyalgia symptoms was assessed using the Revised fibromyalgia Impact Questionnaire, which measures functional impairment, overall impact, and symptom severity in fibromyalgia patients. The total score ranges from 0 to 100, with higher scores reflecting greater disease burden and worse functional status.)
Measured: Baseline/ at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start28 Nov 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 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 FibromyalgiaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 194 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zehra Duman Sahin, MD, Study chair, Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777667
- Sponsor's protocol ID
- AntalyaCityHospital
- Acronym
- FSRRFD
- Status last verified
- Apr 2025
- First submitted
- 11 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
PubMed 27189527Casale R, Sarzi-Puttini P, Botto R, Alciati A, Batticciotto A, Marotto D, Torta R. Fibromyalgia and the concept of resilience. Clin Exp Rheumatol. 2019 Jan-Feb;37 Suppl 116(1):105-113. Epub 2019 Feb 8.
PubMed 30747098Sil S, Lynch-Jordan A, Ting TV, Peugh J, Noll J, Kashikar-Zuck S. Influence of family environment on long-term psychosocial functioning of adolescents with juvenile fibromyalgia. Arthritis Care Res (Hoboken). 2013 Jun;65(6):903-9. doi: 10.1002/acr.21921.
PubMed 23281206Collin SM, Bakken IJ, Nazareth I, Crawley E, White PD. Trends in the incidence of chronic fatigue syndrome and fibromyalgia in the UK, 2001-2013: a Clinical Practice Research Datalink study. J R Soc Med. 2017 Jun;110(6):231-244. doi: 10.1177/0141076817702530. Epub 2017 Mar 30.
PubMed 28358988Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
PubMed 19664287Ediz L, Hiz O, Toprak M, Tekeoglu I, Ercan S. The validity and reliability of the Turkish version of the Revised Fibromyalgia Impact Questionnaire. Clin Rheumatol. 2011 Mar;30(3):339-46. doi: 10.1007/s10067-010-1546-8. Epub 2010 Aug 12.
PubMed 20703890Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
PubMed 18157881Fowler PC. Factor structure of the Family Environment Scale: effects of social desirability. J Clin Psychol. 1982 Apr;38(2):285-92. doi: 10.1002/1097-4679(198204)38:23.0.co;2-9.
PubMed 7068862
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resilience and Family Dynamics on Disease Severity in Women With Fibromyalgia: Comparison With Healthy Controls
- ClinicalTrials.gov ID
- NCT06777667
- Acronym / sponsor ID
- FSRRFD / AntalyaCityHospital
- Conditions
- Fibromyalgia, Resilience
- Keywords
- Fibromyalgia, Connor-Davidson Resilience Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jan 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 survey study aims to examine the resilience and family dynamics between newly diagnosed fibromyalgia (FM) patients and healthy individuals. The study will analyze demographic data including parental attitude and childhood trauma and resilience levels using the Connor-Davidson Resilience Scale (CD-RISC-10) in fibromyalgia patients and healthy controls. The Revised Fibromyalgia Impact Questionnaire (FIQR) will also be administered to FM patients to determine the total impact and severity of the disease (mild, moderate, severe, very severe). In addition to aiming to reveal how FM patients compare to healthy individuals in terms of resilience and parental attitude, this study will also examine the relationship between disease severity and these psychosocial variables. As a result, the data obtained are expected to reveal both potential differences in resilience and family problems in FM patients and the relationship of these factors with disease severity.
Detailed description
FM is a common disease worldwide, characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is estimated that symptoms are seen in around 2-4% of the population. Although FM is due to a complex disease model triggered by biological and psychosocial variables, the details are still unclear.
While psychological resilience plays a critical role in coping with stress and chronic pain, a supportive family environment can contribute to individuals developing effective coping mechanisms. Research shows that low resilience levels can trigger FM and a controlling family environment can negatively affect emotional functioning.
The increase in the incidence of FM in recent years has placed additional burdens on the healthcare system. Therefore, it is necessary to provide new perspectives that will guide clinicians who face FM and contribute to improving treatment processes.
The research aims to develop a deep understanding of the etiology and course of FM, as well as to contribute to customizing individual treatment approaches and health services by revealing the effects of psychosocial factors. This study will contribute to the understanding of the relationships between psychological resilience, family dynamics and disease severity in fibromyalgia patients. The data to be obtained will help develop new perspectives and suggestions for clinical practices by emphasizing the importance of psychological support and family dynamics in the treatment processes of fibromyalgia. In addition, comparisons with healthy controls may lead to a better understanding of the needs of individuals with FM. Another important benefit expected from the study is to place more emphasis on the importance of resilience and problems in child development. These studies have the potential to reduce the risks of developing FM and similar diseases in tomorrow's adults. In this context, primary prevention strategies may contribute to public health and the burden on the health system.
This study aims to examine the relationships between psychological resilience, childhood problems and severity of fibromyalgia symptoms between FM patients and healthy control groups. In particular, it was aimed to determine which elements significantly affect symptom severity by evaluating the effects of these factors on FM.
The hypotheses of the study:
Hypothesis 1: Individuals with low psychological resilience and a negative parental attitude during childhood will experience more severe FM symptoms.
Hypothesis 2: FM patients will have lower psychological resilience and more negative parental attitude compared to healthy controls.
Rationale for the study:
FM is a common disease characterized by chronic widespread pain, sleep problems, physical fatigue, and cognitive difficulties. It is characterized by chronic widespread pain, somatic symptoms, and cognitive difficulties. FM is seen in all populations worldwide, and the prevalence of symptoms varies between 2% and 4% in the general population. A model has been proposed for the pathogenesis of FM in which biological and psychosocial variables influence the susceptibility, triggering, and worsening of a chronic disease, but the details are unclear.
FM is a complex and multifactorial disorder, and the severity of its symptoms may be affected by the individual's psychosocial circumstances. While psychological resilience plays a critical role in coping with chronic pain and stress, a supportive family environment may encourage individuals to develop effective coping mechanisms. There may be a link between FM and resilience, as resilience is closely related to an individual's response to acute or chronic stress, which can affect chronic pain conditions such as FM. Resilience is a complex structure that is contributed by genetics and environmental factors, and in some individuals, these factors may help to develop a personality that is more resilient to stressful life events. Therefore, low resilience may be a trigger for FM. The family environment may also be a factor contributing to the complex structure of fibromyalgia. Previous research has found that a controlling (highly regimented and less independent) family environment in early adolescence is a key factor predicting poorer long-term emotional functioning in juvenile FM patients. Reports indicate that the incidence of fibromyalgia increased from 2001 to 2013, suggesting that the healthcare system will be further burdened by the management of this disease. This study will provide important guidance for clinicians facing FM and will help to provide new perspectives on the management of the disease.
This study aims to better understand the potential contributions and effects of these factors on the health of individuals by examining the effects of psychological resilience and family environment on the severity of fibromyalgia. The findings to be obtained in these areas may contribute to the development of individual treatment approaches and the customization of health services.
This study will provide data that can help improve treatment processes by developing a deeper understanding of the etiology and course of FM. In addition, understanding the role of psychosocial and environmental factors will allow the development of more targeted interventions for clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia group | – | –Individuals diagnosed with fibromyalgia according to the 2016 ACR criteria. Participants will be recruited from the Physical Medicine and Rehabilitation Clinic at Antalya City Hospital. Inclusion Criteria: Female, aged 25-45 years Diagnosis of fibromyalgia according to the 2016 revision of 2010/2011 ACR criteria Able to provide informed consent |
| Healthy control group | – | –Age- and sex-matched healthy female individuals. No diagnosis of fibromyalgia or any other chronic pain condition. Recruited from the community or other appropriate sources. Inclusion Criteria: * Female, aged 25-45 years * No history of fibromyalgia or other chronic pain conditions * Able to provide informed consent |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include adult females aged 25-45 years. Participants will be divided into two groups: (1) individuals with a diagnosis of fibromyalgia and (2) healthy female controls within the same age range. All participants will be recruited through convenience sampling, such as patients visiting the Physical Medicine and Rehabilitation Clinic at Antalya City Hospital, and will provide written informed consent.
Key inclusion criteria (3 listed)
- Age range: Women between the ages of 25-45.
- Diagnosis: For fibromyalgia Group: Individuals diagnosed according to the 2016 revision of the American College of Rheumatology's 2010/2011 fibromyalgia diagnostic criteria. For healthy Control Group: Healthy women without a fibromyalgia diagnosis.
- Consent: Individuals who volunteered to participate in the research processes and gave informed consent regarding the details of participation and signed the consent form.
Key exclusion criteria (2 listed)
- Serious medical conditions: Individuals with serious health problems such as autoimmune diseases, cancer, severe heart and lung diseases, or acute pain caused by trauma, surgery, inflammatory joint diseases, etc.
- Psychiatric conditions: Individuals with psychiatric diseases, medication use, or whose mental state may affect their ability to understand and complete the survey questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience levels
Time frame: Baseline/ at the time of enrollment
Comparison of resilience scores between fibromyalgia patients and healthy controls. (Resilience was measured using the 10-item Connor Davidson- Resilience Scale, which ranges from 0 to 40, with higher scores reflecting greater resilience and better psychological adaptability.)
1 secondary outcome
Correlation between resilience and the severity of fibromyalgia symptoms.
Time frame: Baseline/ at the time of 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 30 Apr 2025.
- Background: PubMed 27189527Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
- Background: PubMed 30747098Casale R, Sarzi-Puttini P, Botto R, Alciati A, Batticciotto A, Marotto D, Torta R. Fibromyalgia and the concept of resilience. Clin Exp Rheumatol. 2019 Jan-Feb;37 Suppl 116(1):105-113. Epub 2019 Feb 8.
- Background: PubMed 23281206Sil S, Lynch-Jordan A, Ting TV, Peugh J, Noll J, Kashikar-Zuck S. Influence of family environment on long-term psychosocial functioning of adolescents with juvenile fibromyalgia. Arthritis Care Res (Hoboken). 2013 Jun;65(6):903-9. doi: 10.1002/acr.21921.
- Background: PubMed 28358988Collin SM, Bakken IJ, Nazareth I, Crawley E, White PD. Trends in the incidence of chronic fatigue syndrome and fibromyalgia in the UK, 2001-2013: a Clinical Practice Research Datalink study. J R Soc Med. 2017 Jun;110(6):231-244. doi: 10.1177/0141076817702530. Epub 2017 Mar 30.
- Background: PubMed 19664287Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.
- Background: PubMed 20703890Ediz L, Hiz O, Toprak M, Tekeoglu I, Ercan S. The validity and reliability of the Turkish version of the Revised Fibromyalgia Impact Questionnaire. Clin Rheumatol. 2011 Mar;30(3):339-46. doi: 10.1007/s10067-010-1546-8. Epub 2010 Aug 12.
- Background: PubMed 18157881Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
- Background: PubMed 7068862Fowler PC. Factor structure of the Family Environment Scale: effects of social desirability. J Clin Psychol. 1982 Apr;38(2):285-92. doi: 10.1002/1097-4679(198204)38:23.0.co;2-9.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Zehra Duman Sahin, MD study chair
Physical Medicine and Rehabilitation
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 Fibromyalgia and Resilience, run by Antalya Training and Research Hospital 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 3 inclusion and 2 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 30 Apr 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?
Resilience levels (time frame: Baseline/ at the time of enrollment). 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 NCT06777667, 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 30 Apr 2025.