Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/07/2016
Date assigned
29/07/2016
Last edited
01/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 11% of all babies born worldwide are preterm (premature), meaning that they are born more than three weeks before their due date. In many cases, infants are admitted to a neonatal intensive care unit (NICU), as they need comprehensive medical care to ensure their survival. Many of these infants have to undergo painful procedures as part of their standard care in these units. Recent studies have shown that preterm infants are able to experience pain and are particularly susceptible to feeling pain because of their immature and vulnerable nervous systems. Undergoing repetitive and prolonged pain can have damaging short-term effects, such as excessive crying, choking, gagging, vomiting and long-term effects such as altered pain sensitivity, permanent nervous system defects and behavioral problems. Therefore, there is an urgent need to find safe effective treatments to relieve pain among these infants. Music combined touch therapy (MCT) is a type of treatment which combines listening to music and gentle touching of the skin. Previous studies have shown that it can be an effective way of alleviating pain in infants. The aim of this study is to investigate the effects of MCT in lowering pain experienced by premature infants during routine painful procedures in NICU.

Who can participate?
Infants born at least three weeks early who have been admitted to the NICU at Nanjing Children’s Hospital within 72 hours of birth

What does the study involve?
Practices are randomly allocated to one of two groups. Infants in the first group undergo their routine painful procedures as usual, without any extra treatment. Infants in the second group undergo their routine painful procedures with the addition of MCT. This involves having a CD player placed 15-20cm above their heads, which plays lullabies continuously from five minutes before the procedure starts until 30 minutes after it ends. The touch therapy involves the assistance gently placing their left hand on the infant’s head with the fingertips on the eyebrow line and the palm on the infant’s crown, and their right hand with the thumb on the infant’s right shoulder and the rest of the hand on the infant’s arm. At the start of the study, infants in both groups are examined for signs of pain and have samples of blood taken to measure levels of cortisol (a hormone released when stressed) and beta-endorphin (a chemical messenger that produces a numbing effect).

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those taking part in this study.

Where is the study run from?
Nanjing Children’s Hospital Affiliated to Nanjing Medical University (China)

When is the study starting and how long is it expected to run for?
January 2011 to December 2012

Who is funding the study?
Nanjing Children’s Hospital Affiliated to Nanjing Medical University (China)

Who is the main contact?
Dr Jie Qiu

Trial website

Contact information

Type

Public

Primary contact

Dr Jie Qiu

ORCID ID

Contact details

Department of Newborn Infants
Nanjing Children’s Hospital Affiliated to Nanjing Medical University
72 Guangzhou Road
Nanjing
210008
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of music combined touch therapy on pain response and level of beta-endorphine and cortisol in late preterm infants

Acronym

Study hypothesis

The combined music and touch intervention might decrease the pain response of preterm neonates.

Ethics approval

Nanjing Children’s Hospital Affiliated to Nanjing Medical University Ethics Committee, 31/05/2011, ref: #201601035-1.1

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cortisol and β-endorphin levels in pre-term infants

Intervention

After consent is obtained from parents, infants are randomly assigned to either the experimental or control group using a random numbers table. Participants in both groups undergo a range of painful procedures during their standard medical care in the NICU.

Control group: Infants receive daily painful procedures without intervention

Experimental group: Infants receive painful procedures as well as the combined music and touch intervention (CMT). A CD player (Philips AZ-1103) is used for the music intervention. Audio stimulation is provided by “Smart Baby Lullaby” compact discs. The music includes lullabies and nursery rhymes, which are musically simple songs with lower pitch and slower tempo. The disc player is placed approximately 15-20 cm above the infants’ heads, allowing for continuous play of the music from 5 minutes before the experimental procedure until 30 minutes after the procedure. The touch intervention protocol (Gentle Human Touch, GHT), starts from the beginning of procedures until 10 min after the procedure. It involves the assistant gently placing her left hand on the infant’s head with the fingertips resting immediately above the eyebrow line and the palm touching the infant’s crown. The right hand is then placed with the right thumb on the infant’s right shoulder (at midline position) with the rest of her hand and fingers on the infant’s arm above the elbow. These procedures are repeated for every painful procedure during the two weeks data collection period.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Pain is measured using the premature infants’ pain profile (PIPP) at baseline and 2 weeks.

Secondary outcome measures

1. Cortisol levels are measured using blood testing at baseline and 2 weeks
2. Beta-endorphin levels are measured using blood testing at baseline and 2 weeks

Overall trial start date

01/01/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admitted within 72 hours after birth
2. Gestational age is less than 37 weeks

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

30 infants each group

Participant exclusion criteria

1. Serious birth injuries
2. Serious malformations (especially in oral cavity or external ear deformity)
3. Significant parenchyma brain injury (IVH grade IV, or PVL)
4. Had received analgesics or sedatives within 72 h of the assessment
5. Failed hearing screening.

Recruitment start date

01/06/2011

Recruitment end date

31/03/2012

Locations

Countries of recruitment

China

Trial participating centre

Nanjing Children’s Hospital Affiliated to Nanjing Medical University
72 Guangzhou Road
Nanjing
210008
China

Sponsor information

Organisation

Nanjing Children’s Hospital Affiliated to Nanjing Medical University

Sponsor details

72 Guangzhou Road
Nanjing
210008
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Nanjing Health Bureau

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the journal BMC Pediatrics.

Intention to publish date

31/12/2016

Participant level data

To be made available at a later date

Results - basic reporting

See additional file ISRCTN14131492_BasicResults_29Jul16

Publication summary

Publication citations

Additional files

Editorial Notes

01/08/2016: Basic results summary uploaded.