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DISTRACT Trial: A study to evaluate the effects of distraction techniques on post operative pain

DISTRACT Trial: A single centre, single blinded randomised trial evaluating the role of DISTRACTion therapy in pain management following major abdominal surgeries in adult cancer patients. - DISTRACT TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037146
Enrollment
176
Registered
2021-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C15-C26- Malignant neoplasms of digestive organs Health Condition 2: C64-C68- Malignant neoplasms of urinary tract Health Condition 3: O- Medical and Surgical

Interventions

Intervention1: Behavioural (distraction) therapy: According to the institutionâ??s Acute Pain Service management of pain in the post operative period, all patients will have a routine management. Alon

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Patient with no or mild systemic disease not incapacitating physical mobility 2- surgeries- hepatectomy( wedge resection/left hepatectomy), cholecystectomy, nephrectomy with working epidural.

Exclusion criteria

Exclusion criteria: 1-surgeries with multiple incisions that cannot be/is not covered with on going epidural analgesia. 2- patient not willing for participation in the trial. 3- patient not willing to engage in any of the non-pharmacological methods in the immediate post operative period if the need be. 4- patient on chronic pain medication or psychiatric illness. 5- on screening, patient involved in distraction activities on a daily basis. Exclusion criteria on Post operative day1 1- absence of demonstrable band covering the entire surgical incision. 2- persistent hypotension precluding the use of epidural analgesia to optimum. 3- need of prolonged ICU stay beyond post operative day 1. 4- any altered labs/clinical condition preventing the use of paracetamol and tramadol in post operative period. 5- patient in severe pain despite epidural and needing a patient controlled analgesia pump(PCA) in addition to epidural analgesia.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of distraction techniques in reducing post-operative pain from post-operative day 1 of surgery in patients undergoing abdominal surgeries, compared in terms of need of rescue analgesia in addition to ongoing epidural analgesia.Timepoint: Filling a questionnaire (Revised American Pain Society Outcome Questionnaire) on post operative day 4/during discharge ( whichever is earlier)

Secondary

MeasureTime frame
Comparing patient outcomes with respect to severity of pain, pain interference to daily activities, pain affection on mood and emotions and patient satisfaction as per responses received from questionnaire adapted from the revised American pain society patient outcome questionnaire. (included in CRF) â?¢ To compare impact of pain management on bowel movements recorded as time to first passage of flatus post-surgery. â?¢ To compare impact of pain management on time for discharge of patient from the hospital â?¢ To compare impact on persistent post-surgical pain assessed on first follow up in the hospital using Brief Pain Inventory (BPI) scale.Timepoint: 1-Filling the questionnaire (Revised American Pain Society Outcome Questionnaire) on post operative day 4/ during discharge (whichever is earlier) 2- filling Brief Pain Inventory (BPI) scale on one month follow up

Countries

India

Contacts

Public ContactDr Chandni Rana

Tata Memorial Hospital, Mumbai

sumitabakshi@yahoo.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026