Postoperative Pain, AcuteNCT05452967
Comparison of Pain Scores by Using Audiovisual Aids.
A study testing Distraction technique in people with Postoperative Pain, Acute, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Distraction technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74800
Shemila Abbasi, FCPS, 92134862896 ext. 2896, shemila.abbasi@aku.edu
Saima Rashid, FCPS, 92134864637 ext. 4637, saima.rashid@aku.edu
About this study
Official title: Comparison of Pain Scores by Using Audiovisual Distraction Aids in Post Operative Paediatric Patients.
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.
Read the 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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Distraction technique
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction techniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional analgesia group Group C | No intervention | this group will receive rescue analgesia as per need |
| Distraction group: Group CD | Experimental | 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 Receives: Other: Distraction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: After concluding /last reading at 45 minutes parents satisfaction will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion8 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group C (conventional analgesia group) Group CD (conventional analgesia plus distraction technique)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shemila Abbasi, Aga Khan University
- Investigators
- Shemila Abbasi, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452967
- Sponsor's protocol ID
- 2172-14474
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Scores by Using Audiovisual Distraction Aids in Post Operative Paediatric Patients.
- ClinicalTrials.gov ID
- NCT05452967
- Acronym / sponsor ID
- 2172-14474
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 8 Jun 2023 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group C (conventional analgesia group) Group CD (conventional analgesia plus distraction technique)
| Arm | Type | Receives |
|---|---|---|
| Conventional analgesia group Group C | No intervention | –this group will receive rescue analgesia as per need |
| Distraction group: Group CD | Experimental | Other: Distraction techniqueThis 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 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction techniqueThe 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 | Other | Distraction group: Group CD |
Primary outcome
Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
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.
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.
1 secondary outcome
Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients.
Time frame: After concluding /last reading at 45 minutes parents satisfaction will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shemila Abbasi, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction technique in people with Postoperative Pain, Acute, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shemila Abbasi, FCPS (92134862896 ext. 2896, shemila.abbasi@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pain scores by using audiovisual distraction aids in post operative paediatric patients. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.