search
Back to results

Comparison of Pain Scores by Using Audiovisual Aids.

Primary Purpose

Postoperative Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Distraction technique
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain, Acute

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. All elective cases on pediatric lists including Orthopaedics, plastic surgery, paediatrics surgery.
  2. ASA level I and II with age range between 3 and 7 years will be included in the study.

Exclusion Criteria:

  1. All pediatric patients who are neurologically challenged,
  2. Undergoing head and neck surgery,
  3. Patients undergoing emergency surgery,
  4. cases with difficult airway,
  5. language barrier and whose parents have not consented to participate in the study will be excluded.

Sites / Locations

  • Aga Khan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional analgesia group Group C

Distraction group: Group CD

Arm Description

this group will receive rescue analgesia as per need

This group will be distracted with the help of mobile or tablet and then will assess that rescue analgesia will be needed in post anaesthesia care unit or not

Outcomes

Primary Outcome Measures

Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
The pain scores will be assessed in post anaesthesia care unit by using Wong Baker FACES pain rating scale. This scale comprises of a series of faces ranging from a happy face at "0" or "no hurt" to a crying face at "10" which represents the worst pain imaginable. The higher the score the worse will be the pain. We will use a proforma for data collection and for measuring the desired outcome.

Secondary Outcome Measures

Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
Parent's satisfaction will be assessed once the patient will be signed off from the post anaesthesia care unit.

Full Information

First Posted
December 9, 2021
Last Updated
March 27, 2023
Sponsor
Aga Khan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05452967
Brief Title
Comparison of Pain Scores by Using Audiovisual Aids.
Official Title
Comparison of Pain Scores by Using Audiovisual Distraction Aids in Post Operative Paediatric Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted at post anaesthesia care unit of Department of Anesthesiology, Aga Khan University Hospital Karachi. The aim of this study is to compare the post operative analgesia between two groups of post operative paediatric patients, Conventional group, receiving conventional analgesia and the group of patients in which distraction technique will be used. Conventional group will only receive conventional analgesia while the distraction group will receive conventional analgesia as well as distraction technique. Distraction technique that will be used is a non-pharmacological method of pain relief for post-operative paediatric patients in post anesthesia care unit. (games on tablets, listening poems, watching cartoons). Conventional analgesia is the standardise rescue analgesia of intravenous administration of analgesics in post anaesthesia care unit prescribed. The analgesia will include I/V Tramadol 0.5 to 1mg/kg and Paracetamol 10mg/kg). Our primary outcome will be pain scores using Wong-Baker FACES® pain rating scale and parent's satisfaction as secondary outcome.
Detailed Description
The main purpose of this study is to compare the post operative analgesia between two groups (Conventional and the Distraction Group ) receiving conventional analgesia with or without distraction technique. Conventional group will only receive conventional analgesia while group Distraction group will receive conventional analgesia as well as distraction technique. This randomised controlled trial will be conducted at post anaesthesia care unit of Department of Anesthesiology, Aga Khan University Hospital Karachi after approval by Ethical Review committee. After getting registration from clinical trials, the data will be collected. The purpose along with procedure of the study will be explained to the parents/guardian and informed consent will be taken in the ward. Patients will be divided into two equal groups by computer generated random number and the information will be provided to the investigator in the form of sealed envelopes which will not be opened until patient consent is obtained. The information and the demographics of the patients will be entered in the proforma attached as annexure. Data will be collected in the pre designed form. For the purpose of data collection the form is divided into two sections: SECTION I: - This section will be filled by the primary investigator in operation room. SECTION II: - This section will be completed by the data collector in PACU. When the investigator will receive patients in post anaesthesia care unit, the nurse will be informed about the allocated group. Parents will be present with both groups. Patients in the conventional group will receive their routine rescue analgesics. While patients in the group distraction group will be engaged in distraction methods once the child is awake and his/her response will be noted in form II at given intervals by data collector. Heart Rate, Blood pressure, oxygen saturation and respiratory rate will be noted from the monitors. The pain score will be noted with the help of given Wong Baker faces pain scale (The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more"). on proforma. Routine rescue analgesia (Injection Paracetamol; 15 mg/Kg and Injection Nalbuphine 1/4 dose of the intra operative dose) will be used if patient still experiences pain. The study will be concluded at discharge from the post anaesthesia care unit. These children will be given tablets/smart phone to choose one of the options like playing games, to listening poems and watching cartoons. It will be the responsibility of primary investigator with assistance of data collector. Primary investigator will ensure the study protocol compliance. A copy of the consent form taken will be attached with proforma. The confidentiality of the patient and data will be maintained by assigning a number for each patient data. The electronic data will be password protected and hard copies will be kept in research cell in locked cupboard. At the completion of the study, results will be shared with the parents upon their request. Public disclosure includes publication of an abstract or full paper in a scientific journal and presentation at a scientific meeting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group C (conventional analgesia group) Group CD (conventional analgesia plus distraction technique)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional analgesia group Group C
Arm Type
No Intervention
Arm Description
this group will receive rescue analgesia as per need
Arm Title
Distraction group: Group CD
Arm Type
Experimental
Arm Description
This group will be distracted with the help of mobile or tablet and then will assess that rescue analgesia will be needed in post anaesthesia care unit or not
Intervention Type
Other
Intervention Name(s)
Distraction technique
Intervention Description
The post operative pediatric patients will be given mobile phone in recovery for plying games and watching cartoons and with the help of this distraction technique will assess that routine rescue analgesia is needed or not
Primary Outcome Measure Information:
Title
Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
Description
The pain scores will be assessed in post anaesthesia care unit by using Wong Baker FACES pain rating scale. This scale comprises of a series of faces ranging from a happy face at "0" or "no hurt" to a crying face at "10" which represents the worst pain imaginable. The higher the score the worse will be the pain. We will use a proforma for data collection and for measuring the desired outcome.
Time Frame
Baseline data (hemodynamic variables and pain score) on arrival in the post anaesthesia care unit . First reading at 15 minutes after intervention. Second at 30 minutes and last at 45 minutes. All the readings will be compared with the initial baseline.
Secondary Outcome Measure Information:
Title
Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
Description
Parent's satisfaction will be assessed once the patient will be signed off from the post anaesthesia care unit.
Time Frame
After concluding /last reading at 45 minutes parents satisfaction will be assessed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All elective cases on pediatric lists including Orthopaedics, plastic surgery, paediatrics surgery. ASA level I and II with age range between 3 and 7 years will be included in the study. Exclusion Criteria: All pediatric patients who are neurologically challenged, Undergoing head and neck surgery, Patients undergoing emergency surgery, cases with difficult airway, language barrier and whose parents have not consented to participate in the study will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shemila Abbasi, FCPS
Phone
92134862896
Ext
2896
Email
shemila.abbasi@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Saima Rashid, FCPS
Phone
92134864637
Ext
4637
Email
saima.rashid@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shemila Abbasi, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shemila Abbasi, FCPS
Phone
92134862896
Ext
2896
Email
shemila.abbasi@aku.edu
First Name & Middle Initial & Last Name & Degree
Saima Rashid, FCPS
Phone
92134864637
Ext
4637
Email
saima.rashid@aku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Pain Scores by Using Audiovisual Aids.

We'll reach out to this number within 24 hrs