Exploring the impact of craniosacral therapy versus placebo in adults with insomnia: a randomized control trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- 1 Insomnia severity scale
Study Overview
Brief Summary
The study titled "Exploring the Impact of Craniosacral Therapy Versus Placebo in Adults with Insomnia: A Randomized Controlled Trial" aims to assess the efficacy of craniosacral therapy compared to a placebo in treating insomnia. Adults diagnosed with insomnia will be randomly assigned to receive either craniosacral therapy or a placebo intervention. Baseline data, including demographic information, sleep quality measures, quality of life, and associated symptoms, will be collected using the insomnia severity index ,SF36 and the Flinders fatigue scale. Patients will be assessed at three distinct time points: prior to the intervention (T1), immediately after the intervention (T2) and during a follow-up assessment (15). days after the intervention (T3). Before participating in the study, all individuals will provide signed, written informed consent, ensuring their voluntary participation and compliance with ethical standards outlined by the World Medical Association Declaration of Helsinki principles. All procedures will be conducted in strict adherence to these principles, thereby upholding the ethical integrity of the research and protecting the rights and well-being of the participants throughout the study period.All data will be securely stored and managed according to ethical guidelines. Statistical analyses will compare the outcomes between the two groups to determine the therapy’s efficacy using the latest version of SPSS software
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 includes the age spectrum 2 stable medication use 3 no concurrent psychotherapy for insomnia 4 consent 5 compliance with assessment tools 6 Ability to maintain sleep dairy.
Exclusion Criteria
- •1 pregnancy 2 critical health conditions 3 traumatic brain injury history 4 participation in other sleep studies or clinical trials 5 current abuse or dependency on substances, cognitive deficits 6 failure to follow treatment protocols.
Outcomes
Primary Outcomes
1 Insomnia severity scale
Time Frame: T1: 1 WEEK | T2: 3 WEEK | T3: 5 WEEK
2 SF -36
Time Frame: T1: 1 WEEK | T2: 3 WEEK | T3: 5 WEEK
Secondary Outcomes
- Flinders Fatigue scale(T1: 1 WEEK)
Investigators
Ms Farheen Haider
Lovely professional university , Punjab