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Effect of a Structured Non Pharmacological Care Bundle on Preventing Postoperative Delirium in Older Adults Undergoing Hip Surgery

A Novel Non-Pharmacological Approach to Prevent Postoperative Delirium in Geriatric Hip Surgery Patients A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096202
Enrollment
78
Registered
2025-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: - Health Condition 2: F05- Delirium due to known physiological condition

Interventions

Intervention1: Novel non-pharmacological intervention bundle- CSFMB: Intervention arm (Group A): Structured non pharmacological care bundle (cognitive engagement- 3 times per day, sleep hygiene- 11 PM

Sponsors

Dr Charmi BHimbha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing hip surgery (fracture fixation, total/partial hip replacement). 2)Regional anesthesia (Spinal/Epidural).

Exclusion criteria

Exclusion criteria: 1)Pre-existing delirium, dementia, or major psychiatric disorders. 2)Patients undergoing general anesthesia 3)Severe hepatic/renal impairment. 4)Polytrauma with head injury 5)Epilepsy or Parkinson’s disease. 6)Patients unwilling to participate.

Design outcomes

Primary

MeasureTime frame
Incidence of Delirium (CAM-ICU / CAM for HDU) Timepoint: Outcome assessments will be conducted at baseline (preoperative evaluation) and postoperatively on POD 0, POD 1, POD 2, POD 3, POD 4, POD 5, POD 6, and POD 7, or from POD 0 until discharge, whichever occurs earlier.—

Secondary

MeasureTime frame
Delirium Severity: Measured using the Delirium Rating Scale Revised 98 (DRS R 98) by a psychiatrist for both groups only if CAM ICU score is positive (3 or more). Severity will be documented as mild, moderate, or severe.Timepoint: Outcome will be assessed Postoperatively at 12h, 24h, 36h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 156h, & 168h, or until discharge (whichever occurs earlier);Onset & Duration of delirium,First day of CAM positivity & total number of days positive will be documented.Timepoint: Assessed postoperatively at 12h intervals (12h, 24h, 36h … up to 168h), or until discharge (whichever occurs earlier).;Feasibility & Compliance: Percentage of patients receiving full intervention,The percentage of patients receiving the full intervention will be recorded.Timepoint: At the end of the study period (approximately 6 months).;Hospital Length of StayTimepoint: At discharge;Risk Factor Identification: Patient age, comorbidities, surgery durationTimepoint: At the end of the study, likely at the end of the sixth month.—

Countries

India

Contacts

Public ContactCharmi Bhimbha

All India Institute of Medical Sciences (AIIMS), Rajkot

pacaiimsrajkot@gmail.com

Outcome results

None listed

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