| CTRI Number |
CTRI/2026/02/103735 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [YOGA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga Based Lifestyle Intervention on Symptom Burden and Qualityvof life in patients with ventral Hernia: A Randomised controlled study |
|
Scientific Title of Study
|
A prospective randomised controlled study on the role of Yoga Therapy in alleviating post operatiove pain and distress in patients undergoing Laparoscopic repair of Ventral Hernia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Yadav |
| Designation |
MS General Surgery |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Surgery, AIIMS New Delhi. PIN- 110029
South DELHI 110029 India |
| Phone |
9818041768 |
| Fax |
|
| Email |
ankuryadavay786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devender Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Room No. 413 Surgery Block AIIMS New Delhi. PIN- 110029
South DELHI 110029 India |
| Phone |
9813643337 |
| Fax |
|
| Email |
devender_singh@aiims.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Ankur Yadav |
| Designation |
MS General Surgery |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Department of Surgery Aiims New Delhi. PIN- 110029
South DELHI 110029 India |
| Phone |
9818041768 |
| Fax |
|
| Email |
ankuryadavay786@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr. Devender Singh |
| Address |
Room NO. 413, Aiims, New Delhi. PIN- 110029 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankur Yadav |
All India Institute Of Medical Sciences, New Delhi |
Unit- 1 Department of Surgical Disciplines, Aiims New Delhi, PIN-110029. South DELHI |
9818041768
ankuryadavay786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for PG Reasearch |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K43||Ventral hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard post op care in IPOM and IPOM plus patients |
Standard post op care will be given to this arm. |
| Intervention |
Yoga therapy |
1.The yogasanas will be simpler, may be helpful to reduce abdominal pressure and strengthen the abdominal muscles.
2. Duration/ schedule : 40 to 45 minutes daily, 5 days a week, for 1 months
3. Mode : First 2 weeks offline (physical) mode for training and rest 2 weeks online mode (patients can practice yogasana at their home under the supervision of a yoga therapist).
Each yoga session would be as follows-
1. Prayer
2. Yogic Sukshma Vyayama
- Griva shakti vikasaka
- Skandha chakra
- Purna bhuja shakti vikasaka
- Janu shakti vikasaka kriya
- Gulpha pada- pristha-pada tala shakti vikasaka kriya
3. Asana -
Standing
- Utkatasana
- Virabhadrasana 2
Sitting
- Vajrasana
- Chakki chalanasana
- Marjariasana
- Naukasana
Supine
- Eka pada uttana padasana
- Eka pada pawanmuktasana
- Pawanmuktasana
- Shavasana
4. Pranayama
- Anulom Vilom
- Bhramari
5. Prayer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Patients with ventral hernia-Reducible, Uncomplicated (primary as well as incisional with defect size less than 6cm) who are planned for laparoscopic mesh repair(IPOM or IPOM plus).
-Duration of surgery less than 2hrs
-Age more than or equal to 18 years and less than 65 years
- BMI more than or equal to 18.5 and less than 35
|
|
| ExclusionCriteria |
| Details |
- Unfit for General anaesthesia and Laparoscopy - deranged coagulation profile.
- Hernias other than ventral hernias.
- Hernias undergoing Laparoscopic eTEP or Laparoscopic vTAPP repair
- Irreducible or strangulated hernias.
- Parastomal or recurrent hernias or incisional hernias.
- Rectal diastasis or femoral hernia pts.
- Physically challenged.
- Hyperesthesia.
- Pregnant, OSA, active TB, history of seizures, dementia, previous abdominal surgery, orthopedic disorders(IVDP, sciatica).
- Uncooperative or Refusal.
- Mental retardation.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Post op Pain using Visual assessment pain scale |
6hours, 8hours, 1week, 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mood, chronic inguinal pain, analgesic requirements, functional outcomes |
12,24,48 hours post op and them 1/2/4/8 weeks post op |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="2" 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
|
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Brief Summary
|
While the literature on yoga therapy in surgical patients is extensive, there is a paucity of studies specifically addressing its role in abdominal surgeries such as ventral hernia repair, where immediate postoperative pain and chronic pain are big issues which still need to be addressed. Return to normal work and physical activity can also be hindered as a result of inguinal pain. A pilot study by Sharma et al [24] investigated the feasibility and preliminary efficacy of yoga therapy in improving post-operative outcomes in patients undergoing abdominal surgeries. Although the study focused on a heterogeneous group of abdominal surgery patients, including those undergoing hernia repair, it reported promising results in pain reduction and functional improvement following yoga therapy. Understanding the underlying mechanisms of action of yoga therapy in pain management is crucial for elucidating its potential benefits in surgical patients. Research suggests that yoga interventions may modulate pain perception through various physiological and psychological mechanisms, including activation of the parasympathetic nervous system, reduction of inflammation and stress hormones, enhancement of self-awareness and mindfulness, and promotion of relaxation and coping skills. Reviews by Cramer et al [5] provide comprehensive overviews of the mechanisms and neurobiological effects of yoga therapy in pain management across different populations. Assessing patient preferences and acceptability of yoga therapy interventions is essential for informing the design and implementation of clinical trials in surgical populations. Qualitative studies exploring patient experiences with yoga therapy in pain management have highlighted factors such as perceived effectiveness, enjoyment, sense of empowerment, and satisfaction with the holistic approach. Understanding patient perspectives can inform patient-centred care and enhance adherence to yoga interventions in post-operative settings. While the primary focus of this study is on post-operative pain management, exploring the broader effects of yoga therapy on surgical outcomes and to provide valuable context and insights. Studies by Innes and Vincent[18] and Bussing et al.[25] have investigated the effects of yoga interventions on perioperative anxiety, stress, immune function, and recovery outcomes in surgical patients. Considering these broader outcomes alongside pain management can enhance the comprehensiveness and inform holistic approaches to post-operative care. Patient education and empowerment are integral components of holistic healthcare delivery. Research by Telles et al.[26] and Evans et al.[27] has explored the role of yoga therapy in enhancing patient self-management skills, self-efficacy, and self-care behaviours, which can contribute to improved post-operative outcomes and long-term well-being. Integrating patient education components into yoga therapy interventions can foster active patient engagement and facilitate self-directed pain management strategies. Evaluating the cost-effectiveness of complementary therapies such as yoga in surgical care is essential for healthcare resource allocation and decision-making. Economic evaluations conducted by Herman et al.[28] and Saper et al.[29] have assessed the cost-effectiveness and cost-benefit ratios of yoga interventions in various clinical populations, highlighting potential healthcare cost savings and improved health outcomes. Investigating the cost-effectiveness of yoga therapy in post-operative pain management can provide valuable evidence for healthcare policymakers and stakeholders. In conclusion, the literature suggests that yoga therapy holds promise as a complementary intervention in alleviating post-operative pain and improving overall well-being. The current literature supports the potential role of yoga in reducing inflammatory markers in post-operative patients. While direct evidence in ventral hernia patients is limited, the broader body of research suggests that yoga can effectively modulate inflammation through various mechanisms. Further research specifically focusing on ventral hernia patients, is warranted to confirm these benefits and to establish standardized protocols for integrating yoga into standard post-operative care |