Pain, AcuteNCT03366623
Procedural Pain in Children: Intervention With the Hospital Clown
A study testing Hospital clown and No hospital clown intervention in people with Pain, Acute and Venous Puncture, run by Aalborg University Hospital.
Trial summary
This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care. Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Venous Puncture, Children, Adult
- What is being tested?
- Hospital clown and No hospital clown intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2016to 18 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 4 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Acutely admitted to the hospital
- Scheduled for the venipuncture procedure
- Not prepared for the procedure before coming to the hospital
- Accompanied by at least one parent
Who cannot join
- Subjects with developmental disorders who could not cooperate with self- reporting of pain
- Subjects who were unable to speak Danish or English
About this study
Official title: Hospitalized Children's Pain Experience. Effect and Influence of Intervention With the Hospital Clown in Acute and Repeated Painful Procedures. A Mixed Method Study.
This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.
Read the detailed description
Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures.
The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care.
Methods: A two-faced mixed methods study design with merging and connecting results and findings.
- A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture.
- An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.
- An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.
- Conditions
- Pain, Acute, Venous Puncture, Children, Adult
- Being tested
- Hospital clown, No hospital clown intervention
- Keywords
- Pain assessment, Self report, Hospital clown intervention
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital clownBehavioural
Presence of the hospital clown
No hospital clown interventionBehavioural
Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hospital clown intervention | Other | The performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure.
The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel. Receives: Behavioral: Hospital clown |
| No hospital clown intervention | Other | The clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques. Receives: Behavioral: No hospital clown intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
Self-reported pain measure conducted after finishing the venipuncture in the examining room
Measured: During a time interval of between 0-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start18 Apr 2016
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Helle Nygård kristensen, Aalborg University Hospital
- Investigators
- Helle N Kristensen, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366623
- Sponsor's protocol ID
- Pediatric pain 2017
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalized Children's Pain Experience. Effect and Influence of Intervention With the Hospital Clown in Acute and Repeated Painful Procedures. A Mixed Method Study.
- ClinicalTrials.gov ID
- NCT03366623
- Acronym / sponsor ID
- Pediatric pain 2017
- Conditions
- Pain, Acute, Venous Puncture, Children, Adult
- Keywords
- Pain assessment, Self report, Hospital clown intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 8 Dec 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.
This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.
Detailed description
Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures.
The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care.
Methods: A two-faced mixed methods study design with merging and connecting results and findings.
- A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture.
- An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.
- An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital clown intervention | Other | Behavioral: Hospital clownThe performance of the hospital clown included creating a relation with the child by using different techniques in the venipuncture procedure. The hospital clown used distraction techniques with music, songs, toys, fake tattoos (a small sticker/label with a picture applied to the skin with water), dream journeys, storytelling and making agreements in collaboration with the child, parents and healthcare personnel. |
| No hospital clown intervention | Other | Behavioral: No hospital clown interventionThe clinical staff, defined as pediatric nurses and biomedical laboratory technologists, assisted the child in the venipuncture procedure with conventional communication, comfort and care techniques. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Acutely admitted to the hospital
- Scheduled for the venipuncture procedure
- Not prepared for the procedure before coming to the hospital
- Accompanied by at least one parent
Key exclusion criteria (2 listed)
- Subjects with developmental disorders who could not cooperate with self- reporting of pain
- Subjects who were unable to speak Danish or English
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 |
|---|---|---|
| Hospital clownPresence of the hospital clown | Behavioural | Hospital clown intervention |
| No hospital clown interventionPresence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure. | Behavioural | No hospital clown intervention |
Primary outcome
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale
Time frame: During a time interval of between 0-5 minutes
Self-reported pain measure conducted after finishing the venipuncture in the examining room
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 8 Dec 2017.
- 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.
Helle N Kristensen principal investigator
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hospital clown and No hospital clown intervention in people with Pain, Acute and Venous Puncture, run by Aalborg University Hospital.
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 4 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 8 Dec 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?
Pain intensity measure on a FACES Pain Scale combined with a Numerical 0-10 Rating Scale (time frame: During a time interval of between 0-5 minutes). 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 8 Dec 2017.