Effects of Craniosacral Therapy in Primary Caregivers of Individuals With Special Needs

NCT07443527 | Not Yet Recruiting

• 1 other identifier: IRB-2025-04-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Depression; Body Awareness; Quality of Life; Caregiver Burden; Primary Caregivers of Individuals With Special Needs

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

Outcome Measures

Primary Outcomes (4)

• 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)

  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).

  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).

  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).

  Baseline and Week 4

Secondary Outcomes (3)

• Change in systolic blood pressure (mmHg)

  Baseline and Week 4 (Intervention group: measured before and after each session)

• Change in diastolic blood pressure (mmHg)

  Baseline and Week 4 (Intervention group: measured before and after each session)

• Change in heart rate (beats per minute)

  Baseline and Week 4 (Intervention group: measured before and after each session)

Study Arms (2)

Craniosacral Therapy Group

EXPERIMENTAL

Participants in this group will receive craniosacral therapy according to the study protocol.

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.

Interventions

Craniosacral Therapy OTHER

Craniosacral therapy is a non-pharmacological, manual therapy approach applied by a trained practitioner according to a standardized protocol.

Also known as: Craniosacral Treatment

Craniosacral Therapy Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

Istanbul Rumeli University

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden; Pain; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ozden Baskan

CONTACT

+90 212 866 01 01; ozdenbaskan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be assigned to either an intervention group or a control group in parallel.

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: March 2, 2026
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)