Effects of Craniosacral Therapy in Primary Caregivers of Individuals With Special Needs (CST-PCG)

February 27, 2026 updated by: Ozden Baskan, Istanbul Rumeli University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • Istanbul Rumeli University
        • Contact:
        • Principal Investigator:
          • Ozden Baskan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Craniosacral Therapy Group
Participants in this group will receive craniosacral therapy according to the study protocol.
Other: Craniosacral Therapy
Craniosacral therapy is a non-pharmacological, manual therapy approach applied by a trained practitioner according to a standardized protocol.
Other Names:
  • Craniosacral Treatment
No Intervention: Control Group
Participants in this group will not receive craniosacral therapy or any other therapeutic intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and Week 4
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).
Baseline and Week 4
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).
Baseline and Week 4
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).
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure (mmHg)
Time Frame: Baseline and Week 4 (Intervention group: measured before and after each session)
Systolic blood pressure will be measured using an automated digital sphygmomanometer (Omron® M2 Basic). Values are recorded in millimeters of mercury (mmHg).
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)
Diastolic blood pressure will be measured using an automated digital sphygmomanometer (Omron® M2 Basic). Values are recorded in mmHg.
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)
Heart rate will be measured using an automated digital sphygmomanometer. Values are recorded in beats per minute (bpm).
Baseline and Week 4 (Intervention group: measured before and after each session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Rumeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2025-04-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical considerations and participant confidentiality, as the study involves sensitive personal and health-related information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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