PainNCT03028844
The Effect of a Musical Intervention on Stress Response to Venepuncture
A study testing Music therapy in people with Pain and Stress, Physiological, run by University College Cork at 1 site in Ireland.
Trial summary
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Pain, Stress, Physiological
- What is being tested?
- Music therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2016to Nov 2016
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age)
- Infants must now be >32 weeks corrected gestational age
- Infants who are medically stable and due to have routine venepuncture as part of their management plan
Who cannot join
- Inability to obtain informed consent from parent
- Infants with known hearing impairment
- Infants receiving sedative medications
- Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis
- Infants with congenital abnormalities
- Infants with known EEG abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress
Read the detailed description
The purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels .
The secondary aim of this study is to analyse the effect of music therapy on the EEG, and vital signs of the stable preterm neonate.
- Conditions
- Pain, Stress, Physiological
- Being tested
- Music therapy
- Keywords
- Neonate, preterm, pain, music, EEG, venepuncture
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
The musical intervention will be played for ten minutes prior to venepuncture
| Study group | Role | What they receive |
|---|---|---|
| Sucrose alone | No intervention | These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture |
| Music intervention plus sucrose | Experimental | These infants will receive both oral sucrose solution and music therapy prior to venepuncture. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol levels
Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours
Measured: BASELINE, 20 mins and 4 hours
Secondary outcomes (5)
Premature Infant Pain Profile (PIPP) score
Alteration in pain as measured by Premature Infant Pain Profile (PIPP) score
Measured: immediate
Changes in physiological parameters - Heart rate
Increase in heart rate
Measured: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - respiration rate
Increase in respiration rate
Measured: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - oxygen saturation
Decrease in oxygen saturation
Measured: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - EEG
Altered EEG amplitude and Frequency.
Measured: 10 mins before venepuncture and 10 mins after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gene Dempsey, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028844
- Sponsor's protocol ID
- ED/01/16UCC
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Musical Intervention on Stress Response to Venepuncture
- ClinicalTrials.gov ID
- NCT03028844
- Acronym / sponsor ID
- ED/01/16UCC
- Conditions
- Pain, Stress, Physiological
- Keywords
- Neonate, preterm, pain, music, EEG, venepuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Jan 2017 (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.
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress
Detailed description
The purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels .
The secondary aim of this study is to analyse the effect of music therapy on the EEG, and vital signs of the stable preterm neonate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose alone | No intervention | –These infants will receive an oral sucrose solution ("Sweetease") only prior to venepuncture |
| Music intervention plus sucrose | Experimental | Other: Music therapyThese infants will receive both oral sucrose solution and music therapy prior to venepuncture. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age)
- Infants must now be >32 weeks corrected gestational age
- Infants who are medically stable and due to have routine venepuncture as part of their management plan
Key exclusion criteria (6 listed)
- Inability to obtain informed consent from parent
- Infants with known hearing impairment
- Infants receiving sedative medications
- Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis
- Infants with congenital abnormalities
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 |
|---|---|---|
| Music therapyThe musical intervention will be played for ten minutes prior to venepuncture | Other | Music intervention plus sucrose |
Primary outcome
Salivary cortisol levels
Time frame: BASELINE, 20 mins and 4 hours
Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours
5 secondary outcomes
Premature Infant Pain Profile (PIPP) score
Time frame: immediate
Changes in physiological parameters - Heart rate
Time frame: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - respiration rate
Time frame: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - oxygen saturation
Time frame: 10 mins before venepuncture and 10 mins after
Changes in physiological parameters - EEG
Time frame: 10 mins before venepuncture and 10 mins after
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 23 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Pain and Stress, Physiological, run by University College Cork at 1 site in Ireland.
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 3 inclusion and 6 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 23 Jan 2017. 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 Ireland. 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?
Salivary cortisol levels (time frame: BASELINE, 20 mins and 4 hours). 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 23 Jan 2017.