Effects of Craniosacral Therapy on Pain, Body Awareness, Depression, and Quality of Life in Primary Caregivers of Individuals With Special Needs
Phase: NA
Conditions: Caregiver Burden, Primary Caregivers of Individuals With Special Needs, Pain, Depression, Body Awareness, Quality of Life
Sponsor: Istanbul Rumeli University

Study Protocol  Cover Page 
Official Title of the Study : Effects of Craniosacral Therapy in Primary Caregivers of 
Individuals With Special Needs 
NCT Number: 
Title: Study Protocol 
Document Date:  January 20, 2026 
Sponsor / Institution: Istanbul Rumeli University 
Confidentiality Statement: This document contains confidential information. Participants’ 
names or personal identifiers are not included. 
Brief Description: 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. 
 
 
 
 
 
 
 
 
 
 
 
 

Statistical Cover Page  
Document Title: Statistical Analysis Plan  
Study Official Title: Effects of Craniosacral Therapy in Primary Caregivers of Individuals 
With Special Needs  
NCT Number:  
Date of Document: January 20, 2026  
Sponsor / Institution: Istanbul Rumeli University Confidentiality Statement: This document 
contains confidential information. Participants’ names or personal identifiers are not included.  
Brief Description: Statistical analyses will be conducted using appropriate statistical software 
( SPSS). Continuous variables will be summarized as mean ± standard deviation or median 
(interquartile range), and categorical variables as frequencies and percentages. Normality will 
be assessed using the Shapiro–Wilk test. Statistical significance will be set at p < 0.05 (two-
sided). 
Baseline characteristics of the intervention and control groups will be compared descriptively 
using independent samples t-tests or Mann–Whitney U tests for continuous variables and chi-
square tests for categorical variables. 
Primary outcomes (pain intensity, body awareness, depression, and quality of life) will be 
analyzed by evaluating within-group changes from baseline to post-intervention using paired 
t-tests or Wilcoxon signed-rank tests. Between-group differences in change scores will be 
analyzed using independent samples t-tests or Mann–Whitney U tests.