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NCT Number: NCT07443527

Effects of Craniosacral Therapy 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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Body Awareness Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Primary Caregivers of Individuals With Special Needs Quality of Life Signs and Symptoms Stress, Psychological

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Rumeli University

Istanbul, Turkey (Türkiye)

Location contact

Ozden Baskan

CONTACT

[email protected]

+90 212 8660101

Ozden Baskan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craniosacral therapy

Other

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

Other names: Craniosacral Treatment

Primary outcomes

  1. 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)

  2. 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).

  3. 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).

  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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ozden Baskan

CONTACT

[email protected]

+90 212 866 01 01

Sponsors and collaborators

Lead sponsor

Istanbul Rumeli University

Other

Registry information

Official study title

Effects of Craniosacral Therapy on Pain, Body Awareness, Depression, and Quality of Life in Primary Caregivers of Individuals With Special Needs

Acronym: CST-PCG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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