Caregiver BurdenCST-PCGNCT07443527
Effects of Craniosacral Therapy in Primary Caregivers of Individuals With Special Needs
A study testing Craniosacral Therapy in people with Caregiver Burden and Primary Caregivers of Individuals With Special Needs, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of craniosacral therapy on pain, body awareness, depression, and quality of life in primary caregivers of individuals with special needs. Primary caregivers often experience physical and psychological burden due to long-term caregiving responsibilities. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Primary Caregivers of Individuals With Special Needs, Pain
- What is being tested?
- Craniosacral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female gender
- Being a primary caregiver of an individual with special needs
- Aged between 18 and 55 years
- Caring for an individual who has a valid Special Needs Assessment Report for Children (ÇÖZGER) or a Health Board Report for Adults (ESKR)
- Ability to communicate in Turkish
- Being literate
- Willingness to participate in the study and provide informed consent
Who cannot join
- Pregnancy
- Presence of a neurological condition (e.g., epilepsy, acute cerebrovascular event)
- Presence of tumors or metastatic disease
- Unwillingness to participate in the study
- Inability to cooperate with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Rumeli University
Istanbul, Istanbul
Ozden Baskan, +90 212 8660101, ozdenbaskan@gmail.com
Ozden Baskan
About this study
Official title: Effects of Craniosacral Therapy on Pain, Body Awareness, Depression, and Quality of Life in Primary Caregivers of Individuals With Special Needs
This study aims to evaluate the effects of craniosacral therapy on pain, body awareness, depression, and quality of life in primary caregivers of individuals with special needs.
Primary caregivers often experience physical and psychological burden due to long-term caregiving responsibilities. Craniosacral therapy is a non-pharmacological, manual therapy approach that may help reduce pain, improve body awareness, and support overall well-being.
Read more
In this study, eligible primary caregivers will be assigned to either a craniosacral therapy group or a control group. The intervention group will receive craniosacral therapy sessions, while the control group will receive no therapeutic intervention during the study period. Outcome measures related to pain, body awareness, depression, and quality of life will be assessed before and after the intervention.
The results of this study may contribute to a better understanding of the potential benefits of craniosacral therapy for improving the physical and psychosocial health of primary caregivers of individuals with special needs.
Read the detailed description
This study is designed as a controlled clinical trial to investigate the effects of craniosacral therapy on primary caregivers of individuals with special needs. The study will include an intervention group receiving craniosacral therapy and a control group receiving no therapeutic intervention during the study period.
Eligible participants will be primary caregivers who meet the predefined inclusion criteria related to caregiving duration, daily caregiving responsibilities, and consent to participate. Participants will be allocated to either the intervention or control group according to the study protocol.
Craniosacral therapy will be applied as a non-pharmacological, manual therapy intervention following a standardized treatment approach. The therapy sessions will be conducted by a trained practitioner, and the intervention will be delivered over a defined treatment period.
Outcome measures will focus on pain, body awareness, depression, and quality of life. These outcomes will be assessed at baseline and after completion of the intervention period to evaluate changes associated with the therapy. Standardized and validated assessment tools will be used for all outcome measurements.
The control group will not receive craniosacral therapy or any alternative therapeutic intervention during the study period. This design will allow for comparison between groups and evaluation of the potential effects of craniosacral therapy beyond usual conditions.
The findings of this study are expected to provide methodological and clinical insight into the role of craniosacral therapy as a supportive intervention for the physical and psychosocial well-being of primary caregivers of individuals with special needs.
- Conditions
- Caregiver Burden, Primary Caregivers of Individuals With Special Needs, Pain, Depression, Body Awareness, Quality of Life
- Being tested
- Craniosacral Therapy
- Keywords
- Craniosacral Therapy, Primary Caregivers, Caregiver Burden, Pain, Body Awareness, Depression, Quality of Life, Non-Pharmacological Intervention, Complementary Therapy, Primary Caregivers of Individuals With Special Needs
- Medical subject headings
- Caregiver Burden, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral TherapyOther
Also called Craniosacral Treatment
Craniosacral therapy is a non-pharmacological, manual therapy approach applied by a trained practitioner according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral Therapy Group | Experimental | Participants in this group will receive craniosacral therapy according to the study protocol. Receives: Other: Craniosacral Therapy |
| Control Group | No intervention | Participants in this group will not receive craniosacral therapy or any other therapeutic intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Short-Form McGill Pain Questionnaire (SF-MPQ) total score
Pain intensity will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The total score is calculated from 15 descriptors (11 sensory, 4 affective), each rated from 0 (none) to 3 (severe). Higher scores indicate greater pain intensity. Total score (0-45)
Measured: Baseline and Week 4
Change in Body Awareness Questionnaire (BAQ) total score
Body awareness will be evaluated using the Body Awareness Questionnaire (BAQ), an 18-item self-report scale rated on a 7-point Likert scale. Total scores range from 18 to 126. Higher scores indicate greater body awareness. Total score (18-126).
Measured: Baseline and Week 4
Change in Beck Depression Inventory (BDI) total score
Depression severity will be measured using the Beck Depression Inventory (BDI), a 21-item self-report instrument. Each item is scored from 0 to 3. Total scores range from 0 to 63. Higher scores indicate greater depressive symptom severity. Total score (0-63).
Measured: Baseline and Week 4
Change in Adult Carer Quality of Life Questionnaire (AC-QoL) total score
Quality of life will be assessed using the Adult Carer Quality of Life Questionnaire (AC-QoL), a 40-item instrument covering eight domains related to caregiving. Total scores range from 0 to 120. Higher scores indicate better quality of life. Total score (0-120).
Measured: Baseline and Week 4
Secondary outcomes (3)
Change in systolic blood pressure (mmHg)
Systolic blood pressure will be measured using an automated digital sphygmomanometer (Omron® M2 Basic). Values are recorded in millimeters of mercury (mmHg).
Measured: Baseline and Week 4 (Intervention group: measured before and after each session)
Change in diastolic blood pressure (mmHg)
Diastolic blood pressure will be measured using an automated digital sphygmomanometer (Omron® M2 Basic). Values are recorded in mmHg.
Measured: Baseline and Week 4 (Intervention group: measured before and after each session)
Change in heart rate (beats per minute)
Heart rate will be measured using an automated digital sphygmomanometer. Values are recorded in beats per minute (bpm).
Measured: Baseline and Week 4 (Intervention group: measured before and after each session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either an intervention group or a control group in parallel.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Baskan, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443527
- Sponsor's protocol ID
- IRB-2025-04-08
- Acronym
- CST-PCG
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations and participant confidentiality, as the study involves sensitive personal and health-related information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Craniosacral Therapy on Pain, Body Awareness, Depression, and Quality of Life in Primary Caregivers of Individuals With Special Needs
- ClinicalTrials.gov ID
- NCT07443527
- Acronym / sponsor ID
- CST-PCG / IRB-2025-04-08
- Conditions
- Caregiver Burden, Primary Caregivers of Individuals With Special Needs, Pain, Depression, Body Awareness, Quality of Life
- Keywords
- Craniosacral Therapy, Primary Caregivers, Caregiver Burden, Pain, Body Awareness, Depression, Quality of Life, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Mar 2026 (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 study aims to evaluate the effects of craniosacral therapy on pain, body awareness, depression, and quality of life in primary caregivers of individuals with special needs.
Primary caregivers often experience physical and psychological burden due to long-term caregiving responsibilities. Craniosacral therapy is a non-pharmacological, manual therapy approach that may help reduce pain, improve body awareness, and support overall well-being.
In this study, eligible primary caregivers will be assigned to either a craniosacral therapy group or a control group. The intervention group will receive craniosacral therapy sessions, while the control group will receive no therapeutic intervention during the study period. Outcome measures related to pain, body awareness, depression, and quality of life will be assessed before and after the intervention.
The results of this study may contribute to a better understanding of the potential benefits of craniosacral therapy for improving the physical and psychosocial health of primary caregivers of individuals with special needs.
Detailed description
This study is designed as a controlled clinical trial to investigate the effects of craniosacral therapy on primary caregivers of individuals with special needs. The study will include an intervention group receiving craniosacral therapy and a control group receiving no therapeutic intervention during the study period.
Eligible participants will be primary caregivers who meet the predefined inclusion criteria related to caregiving duration, daily caregiving responsibilities, and consent to participate. Participants will be allocated to either the intervention or control group according to the study protocol.
Craniosacral therapy will be applied as a non-pharmacological, manual therapy intervention following a standardized treatment approach. The therapy sessions will be conducted by a trained practitioner, and the intervention will be delivered over a defined treatment period.
Outcome measures will focus on pain, body awareness, depression, and quality of life. These outcomes will be assessed at baseline and after completion of the intervention period to evaluate changes associated with the therapy. Standardized and validated assessment tools will be used for all outcome measurements.
The control group will not receive craniosacral therapy or any alternative therapeutic intervention during the study period. This design will allow for comparison between groups and evaluation of the potential effects of craniosacral therapy beyond usual conditions.
The findings of this study are expected to provide methodological and clinical insight into the role of craniosacral therapy as a supportive intervention for the physical and psychosocial well-being of primary caregivers of individuals with special needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either an intervention group or a control group in parallel.
| Arm | Type | Receives |
|---|---|---|
| Craniosacral Therapy Group | Experimental | Other: Craniosacral TherapyParticipants in this group will receive craniosacral therapy according to the study protocol. |
| Control Group | No intervention | –Participants in this group will not receive craniosacral therapy or any other therapeutic intervention during the study period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female gender
- Being a primary caregiver of an individual with special needs
- Aged between 18 and 55 years
- Caring for an individual who has a valid Special Needs Assessment Report for Children (ÇÖZGER) or a Health Board Report for Adults (ESKR)
- Ability to communicate in Turkish
Key exclusion criteria (5 listed)
- Pregnancy
- Presence of a neurological condition (e.g., epilepsy, acute cerebrovascular event)
- Presence of tumors or metastatic disease
- Unwillingness to participate in the study
- Inability to cooperate with study procedures
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 |
|---|---|---|
| Craniosacral TherapyAlso: Craniosacral TreatmentCraniosacral therapy is a non-pharmacological, manual therapy approach applied by a trained practitioner according to a standardized protocol. | Other | Craniosacral Therapy Group |
Primary outcome
Change in pain intensity measured by Short-Form McGill Pain Questionnaire (SF-MPQ) total score
Time frame: Baseline and Week 4
Pain intensity will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The total score is calculated from 15 descriptors (11 sensory, 4 affective), each rated from 0 (none) to 3 (severe). Higher scores indicate greater pain intensity. Total score (0-45)
Change in Body Awareness Questionnaire (BAQ) total score
Time frame: Baseline and Week 4
Body awareness will be evaluated using the Body Awareness Questionnaire (BAQ), an 18-item self-report scale rated on a 7-point Likert scale. Total scores range from 18 to 126. Higher scores indicate greater body awareness. Total score (18-126).
Change in Beck Depression Inventory (BDI) total score
Time frame: Baseline and Week 4
Depression severity will be measured using the Beck Depression Inventory (BDI), a 21-item self-report instrument. Each item is scored from 0 to 3. Total scores range from 0 to 63. Higher scores indicate greater depressive symptom severity. Total score (0-63).
Change in Adult Carer Quality of Life Questionnaire (AC-QoL) total score
Time frame: Baseline and Week 4
Quality of life will be assessed using the Adult Carer Quality of Life Questionnaire (AC-QoL), a 40-item instrument covering eight domains related to caregiving. Total scores range from 0 to 120. Higher scores indicate better quality of life. Total score (0-120).
3 secondary outcomes
Change in systolic blood pressure (mmHg)
Time frame: Baseline and Week 4 (Intervention group: measured before and after each session)
Change in diastolic blood pressure (mmHg)
Time frame: Baseline and Week 4 (Intervention group: measured before and after each session)
Change in heart rate (beats per minute)
Time frame: Baseline and Week 4 (Intervention group: measured before and after each session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations and participant confidentiality, as the study involves sensitive personal and health-related information.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniosacral Therapy in people with Caregiver Burden and Primary Caregivers of Individuals With Special Needs, run by Istanbul Rumeli University 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 7 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: opening soon, as of the sponsor's last update on 2 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ozden Baskan (+90 212 866 01 01, ozdenbaskan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Short-Form McGill Pain Questionnaire (SF-MPQ) total score (time frame: Baseline and Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.