Effect of Playing an Audio Clip for Pain and Anxiety Control in Patients While Dressing Burn Wounds

NCT05515302 | Completed

• 1 other identifier: MRC-01-22-239
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to assess the effect of playing patient preferred audio clip for controlling the pain and anxiety in patients while dressing burn wounds. The age group to be selected for this explicit examination is 18 years and above. The researcher will assess the pain and anxiety levels in both experimental and control groups having sample size of 50 each using standardized tools. The patient in intervention group will be offered selected audio clips to choose from. The patient preferred audio clips will be played for 10 days while the control group will be provided with treatment as usual. After collecting the data from both groups, it will be compared to analyze the effectiveness of listening to the audio clips chosen by the patient.

Conditions

Pain; Anxiety

Keywords

pain; anxiety; Burns Patients; Wound Dressing.

Outcome Measures

Primary Outcomes (2)

• change in pain intensity

  Measures the changes in pain intensity with a Numerical Rating Scale from 0-10 with higher score indicates higher levels of pain and lower scores indicates less pain 15-20% in experimental group as compared to control group with treatment as usual.

  Throughout study completion up to 10 days after randomization.

• changes in anxiety level

  Measures the changes in anxiety with Beck Anxiety Inventory scale from 0-63 maximum scores. Higher scores indicate higher levels of anxiety and lower scores indicates lower levels of anxiety.

  Throughout study completion up to10 days after randomization.

Secondary Outcomes (3)

• changes in Heart rate

  Throughout study completion up to10 days after randamization .

• changes in Respiratory rate

  Throughout study completion up to10 days after randomization.

• Changes in Blood Pressure

  Throughout study completion up to 10 days after randomization.

Other Outcomes (1)

• Medication intake

  Throughout study completion up to 10 days after randomization.

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group consists of 50 Participants as per the inclusion criteria. The Audio clips will be administered to the experimental group.

Other: Audio Clip

Control Group

NO INTERVENTION

The control group will not receive the intervention but will receive treatment as usual.

Interventions

Audio Clip OTHER

Selected Audio clips will be introduced to the study subjects during the Burns Dressing Changes. The Audio Clips will be selected as per subjects preference.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients aged 18 years and above.
• Fit the diagnostic standard of severe burn injury as per the clinical guidelines with burns up to10%
• % the total body surface area. (TBSA).
• Hospitalized burn patients with an expected stay in hospital for 10 days at the time of signing the informed consent.
• Patient needs to be literate to understand the instruction and the audio clip and provide response for the questionnaire.
• Pain score before intervention \>=4 NRS (moderate pain

You may not qualify if:

• Burn patients who are critically ill with ventilator support,
• Burn patient with respiratory problem or hearing impairment,
• Burn patients with cognitive impairments.
• Burn patient with diabetic neuropathy

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 82228, Qatar

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None are masked in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: open label Randomized controlled trial

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 25, 2022
• Study Start: August 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)