Precocious PubertyNCT02199587
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test
A study testing Presence of medical clown during endocrine test in people with Precocious Puberty and Growth Hormone Tests, run by Meir Medical Center at 1 site in Israel.
Trial summary
The investigators would like to examine the contribution of medical clowns in routine medical procedures in the endocrine clinic. This will be the first time that will objective evaluate the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and also evaluate the effect of mental… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Precocious Puberty, Growth Hormone Tests
- What is being tested?
- Presence of medical clown during endocrine test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Dec 2014to 1 Aug 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
The investigators would like to examine the contribution of medical clowns in routine medical procedures in the endocrine clinic. This will be the first time that will objective evaluate the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and also evaluate the effect of mental stress on growth hormone secretion in children.
The aim of the current study is testing the pain and anxiety of the patient and the accompanying parent and medical staff in the presence or absence of medical clown at the time:
Read more
- LRH analog (decapeptyl) intramuscular injections for precocious puberty.
- Growth hormone tests.
Secondary end point will be:
- Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone tests in the presence of a clown.
- Does the presence of a medical clown and the mental stress affect the secretion of growth hormone?
- Are there differences in growth hormone secretion and stress hormones between the various tests for growth hormone secretion (glucagon, clonidine or arginine) in the presence of a clown?
- Are there differences in response to stress and the secretion of growth hormone in children with obesity?
Read the detailed description
80 children from the endocrine clinic who are referred for treatment with LRH analog or directed to growth hormone tests, will take part in the study:
1.40 children who are referred to decapeptyl treatment will receive the injection once with a medical clown, and the next time with out the clown and vise verse. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios. The children will be randomly assigned to begin treatment in the presence of a clown and the next injection without medical clown and the second group starts the injections without medical clown and the next shot in the presence of a clown.
2.40 children from endocrine clinic who are referred for growth hormone tests because of short stature will have the test with or without medical clown in a random selection.
Procedure
- Children who receive decapeptyl injections once a month. Before getting the shot will be offered to participate in the study. After signing the consent form and parent consent they randomized to get the treatment in the presence of a clown or without health.
- The kids and their parents who referred to growth hormone test will be offered to participate in the study and after signing the consent will be invited for the test. According to accepted protocol, the children arrived after overnight fast, an intravenous line is inserted and blood is taken for measurement of human growth hormone levels, IGF1, thyroid function test, prolactin, cortisol, and adrenaline and then a stimulates substance (glucagon, clonidine or arginine) is given. Afterward blood tests for human growth hormone and cortisol levels, are taken every 30-60 minutes for approximately 3-4 hours after administration of the provocative substance. During the test regular vital signs are monitored according to Protocol.
In both procedures, anxiety of the child and his parent will be evaluated by questionnaires. State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids. In addition, the kid, his parent and the medical staff will evaluate for pain by Visual Analog Score (VAS).
Inclusion criteria:
- Children older than 4 years.
- referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.
The criteria included:
- The consent of a parent and the child to participate in a study
Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)
Pain assessment scale:
Pain assessment by the child, the parents and the staff (VAS).
- Conditions
- Precocious Puberty, Growth Hormone Tests
- Being tested
- Presence of medical clown during endocrine test
- Keywords
- Medical clown, Growth hormone, Precocious puberty
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of medical clown during endocrine testBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Endocrine test with medical clown | Active comparator | children who are referred to endocrine test will have the procedure with a medical clown, or without. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios Receives: Behavioral: Presence of medical clown during endocrine test |
| Endocrine test without medical clown | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids.
Measured: At 30 min before the procedure and 30 min after the procedure
Secondary outcomes (1)
Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown.
Measured: At 30 min before the test and 30 min after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study start17 Dec 2014
- Primary completion16 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious PubertyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- nitsan dror, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199587
- Sponsor's protocol ID
- MeirMc069-14CTIL
- Status last verified
- Oct 2018
- First submitted
- 18 Jun 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
- ClinicalTrials.gov ID
- NCT02199587
- Acronym / sponsor ID
- MeirMc069-14CTIL
- Conditions
- Precocious Puberty, Growth Hormone Tests
- Keywords
- Medical clown, Growth hormone, Precocious puberty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 17 Dec 2014 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Jul 2014 (estimated)
- 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.
The investigators would like to examine the contribution of medical clowns in routine medical procedures in the endocrine clinic. This will be the first time that will objective evaluate the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and also evaluate the effect of mental stress on growth hormone secretion in children.
The aim of the current study is testing the pain and anxiety of the patient and the accompanying parent and medical staff in the presence or absence of medical clown at the time:
- LRH analog (decapeptyl) intramuscular injections for precocious puberty.
- Growth hormone tests.
Secondary end point will be:
- Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone tests in the presence of a clown.
- Does the presence of a medical clown and the mental stress affect the secretion of growth hormone?
- Are there differences in growth hormone secretion and stress hormones between the various tests for growth hormone secretion (glucagon, clonidine or arginine) in the presence of a clown?
- Are there differences in response to stress and the secretion of growth hormone in children with obesity?
Detailed description
80 children from the endocrine clinic who are referred for treatment with LRH analog or directed to growth hormone tests, will take part in the study:
1.40 children who are referred to decapeptyl treatment will receive the injection once with a medical clown, and the next time with out the clown and vise verse. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios. The children will be randomly assigned to begin treatment in the presence of a clown and the next injection without medical clown and the second group starts the injections without medical clown and the next shot in the presence of a clown.
2.40 children from endocrine clinic who are referred for growth hormone tests because of short stature will have the test with or without medical clown in a random selection.
Procedure
- Children who receive decapeptyl injections once a month. Before getting the shot will be offered to participate in the study. After signing the consent form and parent consent they randomized to get the treatment in the presence of a clown or without health.
- The kids and their parents who referred to growth hormone test will be offered to participate in the study and after signing the consent will be invited for the test. According to accepted protocol, the children arrived after overnight fast, an intravenous line is inserted and blood is taken for measurement of human growth hormone levels, IGF1, thyroid function test, prolactin, cortisol, and adrenaline and then a stimulates substance (glucagon, clonidine or arginine) is given. Afterward blood tests for human growth hormone and cortisol levels, are taken every 30-60 minutes for approximately 3-4 hours after administration of the provocative substance. During the test regular vital signs are monitored according to Protocol.
In both procedures, anxiety of the child and his parent will be evaluated by questionnaires. State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids. In addition, the kid, his parent and the medical staff will evaluate for pain by Visual Analog Score (VAS).
Inclusion criteria:
- Children older than 4 years.
- referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.
The criteria included:
- The consent of a parent and the child to participate in a study
Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)
Pain assessment scale:
Pain assessment by the child, the parents and the staff (VAS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocrine test with medical clown | Active comparator | Behavioral: Presence of medical clown during endocrine testchildren who are referred to endocrine test will have the procedure with a medical clown, or without. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios |
| Endocrine test without medical clown | No intervention | – |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Presence of medical clown during endocrine test | Behavioural | Endocrine test with medical clown |
Primary outcome
change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids.
Time frame: At 30 min before the procedure and 30 min after the procedure
1 secondary outcome
Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown.
Time frame: At 30 min before the test and 30 min after the test
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 15 Oct 2018.
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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.
nitsan dror, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presence of medical clown during endocrine test in people with Precocious Puberty and Growth Hormone Tests, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 15 Oct 2018. 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 Israel. 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?
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?
change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids. (time frame: At 30 min before the procedure and 30 min after the procedure). 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 15 Oct 2018.