A randomized controlled trial to assess the effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh 2014-16.
- Conditions
- Advised for blood sampling
- Registration Number
- CTRI/2016/12/007561
- Lead Sponsor
- Larishisha Risaw
- Brief Summary
**Need and Justification**
Many hospitalized children have to undergo painful procedures. Blood sampling is one of the most common painful procedures the child have to undergo during their hospital stay.
Challenges to the nurses who provide their care, co- operation of children during painful invasive procedures is very important. Nurses are in a unique position to improve the management of children’s pain because children and parents will often tell them things they do not tell physician.
Various studies were found that distraction is a proven effective psychological intervention. Distraction is a power relief intervention that children are accustomed to using. Distraction can be used as one of the strategies to gain co-operation of the child. Distraction is the ability to focus attention on something other than pain and does not mean that the pain is gone.
Therefore, the need to create an evidence based approach to assess the effect of distraction by flippits on behavioral response to pain in children during blood sampling can be articulated.
**Research statement**
A randomized controlled trial to assess the effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh 2014-16**.**
**Objectives**
1. To develop protocol for use of distraction during blood sampling.
2. To assess the effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh.
**Operational definitions**
• Effect – It refers to change in behavioral response to pain level brought about by distraction during blood sampling.
• Distraction – It refers to use of Flippits as a distraction method during blood sampling.
**Delimitation of the study**
The study is limited to children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh**.**
**Null Hypothesis (H****0****)**
There will be no effect of distraction by flippits on behavioral response to pain in children of age group 4 to 6 years during blood sampling at 0.05 level of significance.
**Alternative hypothesis**
H1: Distraction by flippits will lead to reduction of behavioral response to pain in children of age group 4 to 6 years during blood sampling at 0.05 level of significance.
**Delimitation of the study**
The study is limited to children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh**.**
**Nursing implications of the study:**
The findings of the study will:
· Provide an empirical evidence for using distraction by flippits as an alternative non-pharmacological intervention in children of age group 4 to 6 years during blood sampling
Direct the nursing personnel to implement distraction by flippits protocol for children of age group 4 to 6 years during blood sampling
**RESEARCH METHODOLOGY**
• **Approach:** Quantitative
• **Design:** Randomized controlled trial
• **Research setting****:** The study will be conducted in Advanced Pediatric Centre, PGIMER, Chandigarh.
• **Target population:** Children of age group 4 to 6 years who will be advised for blood sampling
• **Study population****:** Children of age group 4 to 6 years who will be advised for blood sampling in Advanced Pediatric Centre, PGIMER, Chandigarh during period of data collection.
• **Sample:** The children meeting the eligibility criteria at the time of data collection will be taken.
• **Sample size:** Approx120 (Experimental: 60; Control: 60)
• **Sampling technique****:** Block randomization
• **Inclusion criteria****:**
Children who are:
1. In the age group of 4 to 6 years
2. Advised for blood sampling
3. Blood sampling through venous approach.
• **Exclusion criteria**
1. Handicapped children- visual & auditory
2. Physical disability
3. Cognitive impairment
**Protocol for Distraction by Flippits**
· Flippits consisted of visual cards of 8 cm to 10 cm, covered with various pictures and shapes appropriate for age group.
· The distraction procedure via Flippits began just before the blood sampling and continued until the end of the blood sampling.
· In this method, the children first carefully examined the cards.
· Then, the researcher will ask some questions about those cards to be answered by the children.
**Protocol For Assessment Of Pain**
**Apparatus:** One video camera will be used to capture clips of the child behavior right from the time is placed on the examination table till the end of the blood sampling procedure.
Ø Assessment of pain will be captured by videotaping using FLACC behavioural pain assessment scale
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
Children who are: 1.In the age group of 4 to 6 years 2.Advised for blood sampling 3.Blood sampling through venous approach.
- 1.Handicapped children- visual & auditory 2.Physical disability 3.
- Cognitive impairment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of distraction by flippits on Behavioral response to pain During blood sampling
- Secondary Outcome Measures
Name Time Method Diference in response to pain in children in both groups During blood sampling
Trial Locations
- Locations (1)
Advanced Pediatric Centre
🇮🇳Chandigarh, CHANDIGARH, India
Advanced Pediatric Centre🇮🇳Chandigarh, CHANDIGARH, IndiaLarishisha RisawPrincipal investigator9855670746l.risaw88@gmail.com