| CTRI Number |
CTRI/2024/03/063708 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hand reflexology massage ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of hand reflexology massage on pain and anxiety in post-Coronary artery bypass graft patients |
|
Scientific Title of Study
|
A study to assess the effectiveness of hand reflexology massage on pain and anxiety in post-CABG patients admitted in AIIMS Bhopal |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meritto Mathew |
| Designation |
M.Sc. Nursing student |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Nursing College, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9109493655 |
| Fax |
|
| Email |
merittom.mscnursing23@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Ranjana Verma |
| Designation |
Assistant Proffessor |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Nursing College, AIIMS Bhopal, Saket Nagar
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9997507733 |
| Fax |
|
| Email |
ranjana.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Meritto Mathew |
| Designation |
M.Sc. Nursing student |
| Affiliation |
All India Institute of Medical Sciences, Bhopal |
| Address |
Nursing College, AIIMS Bhopal, Saket Nagar
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9109493655 |
| Fax |
|
| Email |
merittom.mscnursing23@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mrs Ranjana Verma |
| Address |
Assistant Professor, Nursing College, AIIMS Bhopal, Saket Nagar, Madhya Pradesh, PIN- 462020 |
| Type of Sponsor |
Other [Self- Research guide ] |
|
|
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 |
| Meritto Mathew |
AIIMS Bhopal |
CTVS Ward and CTVS ICU, CTVS Department
Bhopal
MADHYA PRADESH |
9109493655
merittom.mscnursing23@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS Bhopal, Institutional Human Ethics Committee- Student Research |
Approved |
| Institutional Human Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No intervention will be provided |
| Intervention |
Hand reflexology massage |
The anxiety and pain levels of the patients were measured by the researcher before starting the reflexology massage on postoperative day 1.
Hands were washed before starting the massage. The curtains around the patients’ beds were closed. Because the patients had an incision wound in the sternum, they were not moved and kept in the supine position. The hands were supported by a small pillow so that they could be moved easily.
Applied hand reflexology massage according to Inghams method for a total of 20 minutes, first to the right hand and then to the left hand for 10 minutes. First, a general massage was applied to the wrist, palm, back of the hand, and fingers to relax the hand and prepare it for reflexology. Six reflexology points were then identified for stimulation, namely, solar plexus and diaphragm, head and pituitary gland, thyroid and para-thyroid glands, lung point, heart point, and adrenal glands.After the massage was completed, the anxiety levels of the patients were measured at the 60th minute, and the pain levels of the patients were assessed at the 5th, 30th, and 60th minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are 18 years or older
2.Patients who underwent CABG
3.Patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients who are intubated
2.Patients who have a hand deformity
3.Patients who are not hemodynamically stable
4.Patients who have a cannula in their wrists
5.Patients who have been diagnosed with anxiety
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand reflexology massage may have an effect on pain and anxiety among post-CABG patients |
Hand reflexology massage may have an effect on pain and anxiety among post-CABG patients after 1 hour after the massage |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand reflexology massage can be used as a non pharmacological method of pain & anxiety management among post CABG patients |
Hand reflexology massage can be used as a non pharmacological method of pain & anxiety management among post CABG patients which shows effect after 1 hour |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Coronary artery bypass grafting (CABG) is a major surgical operation where atheromatous blockages in a patient’s coronary arteries are bypassed with harvested venous or arterial conduits. The bypass restores blood flow to the ischemic myocardium which, in turn, restores function, and viability, and relieves anginal symptoms. Almost 400,000 CABG surgeries are performed each year making it the most performed major surgical procedure, but surgical trends have decreased as the use of alternative options such as medical treatment and percutaneous coronary intervention (PCI) have increased. Hand reflexology is a massaging technique that works by applying pressure to reflex points within the hands. These reflex points are believed to be connected to other parts of the body, so as massaging occurs, it ensures that the whole body is treated during the reflexology session. Reflexology is a commonly used nonpharmacological complementary method for pain and anxiety management. It is cost-effective and has fewer side effects than pharmacotherapy, fewer skills are required, can be provided at home and community. It is a researchable problem and it will help to reduce the dependence on opioids post-CABG and increase evidence on non-pharmacotherapy-based approaches.
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