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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in pain intensity measured by Short-Form McGill Pain Questionnaire (SF-MPQ) total score [Срок оценки: Baseline and Week 4]
• Change in Body Awareness Questionnaire (BAQ) total score [Срок оценки: Baseline and Week 4]
• Change in Beck Depression Inventory (BDI) total score [Срок оценки: Baseline and Week 4]
• Change in Adult Carer Quality of Life Questionnaire (AC-QoL) total score [Срок оценки: Baseline and Week 4]

Вторичные конечные точки (3)

• Change in systolic blood pressure (mmHg) [Срок оценки: Baseline and Week 4 (Intervention group: measured before and after each session)]
• Change in diastolic blood pressure (mmHg) [Срок оценки: Baseline and Week 4 (Intervention group: measured before and after each session)]
• Change in heart rate (beats per minute) [Срок оценки: Baseline and Week 4 (Intervention group: measured before and after each session)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Rumeli University — Istanbul

Идентификаторы

NCT: NCT07443527 · IRB-2025-04-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗