| CTRI Number |
CTRI/2024/08/072805 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of craniosacral therapy on Insomnia in adults |
|
Scientific Title of Study
|
Exploring the impact of craniosacral therapy versus placebo in adults with insomnia: a randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Farheen Haider |
| Designation |
PG student |
| Affiliation |
Lovely professional university , Punjab |
| Address |
Room number 106, block 3, School of Allied Medical Science , Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab, India.
Kapurthala
PUNJAB
144411
India |
| Phone |
7275014836 |
| Fax |
911824506111 |
| Email |
hfarheen752@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Devi |
| Designation |
Assistant Professor |
| Affiliation |
Lovely professional university |
| Address |
Cabin number 7, Room 213, block 4, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab, India.
Kapurthala
PUNJAB
144411
India |
| Phone |
9056382259 |
| Fax |
911824506111 |
| Email |
drmanjurajput52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Devi |
| Designation |
Assistant Professor |
| Affiliation |
Lovely professional university |
| Address |
Cabin number 7, Room number 213, block 4, School of Allied Medical Sciences , Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Punjab, India.
Kapurthala
PUNJAB
144411
India |
| Phone |
9056382259 |
| Fax |
911824506111 |
| Email |
drmanjurajput52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University,
Delhi-GT road, Phagwara , Punjab, India Pin code 144411 |
|
|
Primary Sponsor
|
| Name |
Ms Farheen Haider |
| Address |
Room number 106, Block 3, School of Allied Medical Sciences, Lovely Professional University, Phagwara, Punjab, India. Pin code: 114441 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manju Devi |
Lovely Professional University |
Room number 101, block 3, School of Allied Medical Science, Lovely Professional University, Delhi G.T. Road, Phagwara, Punjab, India.
Kapurthala
PUNJAB |
9056382268
drmanjurajput52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Lovely professional university ( IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Craniosacral therapy |
This non-invasive, holistic hands-on technique utilizes gentle manual manipulation of the craniosacral system. The aim is to promote relaxation, alleviate tension, and assist with sleep disorders. The techniques used during the sessions will be tailored to the individual patients needs and progress. These techniques may include: (a) sub-occipital inhibition technique; (b) frontal technique; (c) sphenoid technique; (d) fourth ventricle technique; and (e) lumbosacral technique. The therapy sessions will take place 5 days a week for three weeks, with each therapy lasting 6 minutes for a total of 30 minutes. The frequency of the protocol will depend on the patients needs. |
| Comparator Agent |
Placebo technique
|
The placebo technique involves applying a superficial contact that resembles the actual therapy but lacks any therapeutic substance or active mechanism. It is performed by placing both hand palms under the occiput. The technique is administered 5 times a week for 3 weeks, with each session lasting 10 minutes and without touching the occipital muscles. No force, pressure, or movement is applied during the technique. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Insomnia severity scale
2 SF -36 |
T1: 1 WEEK
T2: 3 WEEK
T3: 5 WEEK
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Flinders Fatigue scale |
T1: 1 WEEK
T2: 3 WEEK
T3: 5 WEEK
|
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |