PainNCT03222050
Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
A study testing Distraction technique in people with Pain, run by Maharishi Markendeswar University (Deemed to be University).
Trial summary
A study to assess and compare the effectiveness of Distraction techniques on Pain intensity during Immunization among Infants in selected hospital of Ambala, Haryana. Read more about this study
- Who is it for?
- Ages 10 to 14 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Distraction technique
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jan 2017
- 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 10 to 14 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Infants who were-visiting immunization clinics of Civil Hospital for immunization.
- having 10 and 14 weeks of age. receiving pentavalent vaccine. Parents and caregivers who were willing to give consent
Who cannot join
- The study excluded infants who: had undergone any painful procedure 2 hour prior to immunization, were visually or hearing disabled.
- had history of seizures, use of topical anesthetics at immunization site, use of sedatives, analgesics or opioids in the preceding 24 hours.
About this study
A study to assess and compare the effectiveness of Distraction techniques on Pain intensity during Immunization among Infants in selected hospital of Ambala, Haryana.
Read the detailed description
Immunization is an important part of public health intervention and cost effective strategy to control the infectious diseases especially in children and it is one of the most common painful procedure in infants. Pain during immunization leads to distressing experience for the infant, parents and health care worker. Distraction is non pharmacological method which is used for diverting attention from noxious stimulus by passively redirecting the attention or by actively performed by the subject in the performance of diversion technique. Aim and objectives:The aim of present study was to compare the effectiveness of distraction techniques on pain intensity during immunization among infants. The objectives of the study were to assess and compare the mean pain scores among infants receiving immunization in electronic toy group, key toy group, simple toy group and control group and to find out the association of pain scores among infants receiving immunization with their selected variables. Material and methods: A true experimental multiple intervention post test control design was used. There were 100 infants selected using simple random sampling technique and were randomly allocated in various groups such as electronic toy group, key toy group, simple toy group and control group using lottery method. During immunization, distraction techniques were shown to experimental groups and routine care was given to control group. Research tool was submitted to 7 experts from various specialists for validity. Reliability was calculated by Kappa method and it was 0.83 of FLACC pain scale to assess pain intensity during immunization among infants. Data collection was done in January 2017. The obtained data was analyzed and interpreted in terms of objectives and research hypotheses. Analysis was done by using descriptive and inferential statistics.
- Conditions
- Pain
- Being tested
- Distraction technique
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction techniqueOther
| Study group | Role | What they receive |
|---|---|---|
| electronic toy group | Experimental | Distraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds Receives: Other: Distraction technique |
| key toy group | Experimental | Distraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds Receives: Other: Distraction technique |
| Simple toy group | Experimental | Distraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds Receives: Other: Distraction technique |
| control group | No intervention | Routine care was given during immunization and no intervention was given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flacc pain score
Flacc pain score
Level of pain:
0 - No distress/Pain 1-3 - Mild distress/Pain 4-7 - Moderate distress/Pain 8-10 - Severe distress/Pain
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startNov 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preeti dabas, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222050
- Sponsor's protocol ID
- 777
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Hockenberry Marilyn. Wong's Essentials of Pediatric Nursing. 7th Edition. New Delhi. Elsevier Publication (P) Ltd. 2007; 235-238.
2. Wong DL, Hocken MJ. Nursing care of infants and children and adolescents. Agency for Healthcare Policy and Research Publication. 1992.
9. Sharma Rimple, Kaur Charanjit. A Randomized control trial to assess the effect of distraction technique on pain during immunization among infants. International journal of current research. June 2014:6:7119-7123.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
- ClinicalTrials.gov ID
- NCT03222050
- Acronym / sponsor ID
- 777
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jul 2017 (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.
A study to assess and compare the effectiveness of Distraction techniques on Pain intensity during Immunization among Infants in selected hospital of Ambala, Haryana.
Detailed description
Immunization is an important part of public health intervention and cost effective strategy to control the infectious diseases especially in children and it is one of the most common painful procedure in infants. Pain during immunization leads to distressing experience for the infant, parents and health care worker. Distraction is non pharmacological method which is used for diverting attention from noxious stimulus by passively redirecting the attention or by actively performed by the subject in the performance of diversion technique. Aim and objectives:The aim of present study was to compare the effectiveness of distraction techniques on pain intensity during immunization among infants. The objectives of the study were to assess and compare the mean pain scores among infants receiving immunization in electronic toy group, key toy group, simple toy group and control group and to find out the association of pain scores among infants receiving immunization with their selected variables. Material and methods: A true experimental multiple intervention post test control design was used. There were 100 infants selected using simple random sampling technique and were randomly allocated in various groups such as electronic toy group, key toy group, simple toy group and control group using lottery method. During immunization, distraction techniques were shown to experimental groups and routine care was given to control group. Research tool was submitted to 7 experts from various specialists for validity. Reliability was calculated by Kappa method and it was 0.83 of FLACC pain scale to assess pain intensity during immunization among infants. Data collection was done in January 2017. The obtained data was analyzed and interpreted in terms of objectives and research hypotheses. Analysis was done by using descriptive and inferential statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| electronic toy group | Experimental | Other: Distraction techniqueDistraction technique was given by electronic toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds |
| key toy group | Experimental | Other: Distraction techniqueDistraction technique was given by key toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds |
| Simple toy group | Experimental | Other: Distraction techniqueDistraction technique was given by simple toy during immunization and started 30 seconds before immunization and it lasted until 15 seconds |
| control group | No intervention | –Routine care was given during immunization and no intervention was given |
Who may qualify
- Ages
- 10 to 14 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Infants who were-visiting immunization clinics of Civil Hospital for immunization.
- having 10 and 14 weeks of age. receiving pentavalent vaccine. Parents and caregivers who were willing to give consent
Key exclusion criteria (2 listed)
- The study excluded infants who: had undergone any painful procedure 2 hour prior to immunization, were visually or hearing disabled.
- had history of seizures, use of topical anesthetics at immunization site, use of sedatives, analgesics or opioids in the preceding 24 hours.
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 technique | Other | Simple toy group, electronic toy group, key toy group |
Primary outcome
Flacc pain score
Time frame: 5 minute
Flacc pain score Level of pain: 0 - No distress/Pain 1-3 - Mild distress/Pain 4-7 - Moderate distress/Pain 8-10 - Severe distress/Pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background1. Hockenberry Marilyn. Wong's Essentials of Pediatric Nursing. 7th Edition. New Delhi. Elsevier Publication (P) Ltd. 2007; 235-238.
- Background2. Wong DL, Hocken MJ. Nursing care of infants and children and adolescents. Agency for Healthcare Policy and Research Publication. 1992.
- Results publication9. Sharma Rimple, Kaur Charanjit. A Randomized control trial to assess the effect of distraction technique on pain during immunization among infants. International journal of current research. June 2014:6:7119-7123.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction technique in people with Pain, run by Maharishi Markendeswar University (Deemed to be University).
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 2 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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flacc pain score (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222050, which also lists 3 linked publications.
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 19 Jul 2017.