Condition category
Neonatal Diseases
Date applied
10/01/2019
Date assigned
24/01/2019
Last edited
23/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
During treatment in the neonatal ward, infants receive medical and non-medical care that can cause pain. Prevention and treatment of pain in newborns is very important, but in fact, of the many procedures that cause pain, management of pain carried out by health workers is still very limited. The use of glucose or sucrose (sugar) is more effective for pain relief when it is combined with other sensory stimulus (five senses), known as sensorial saturation (SS). SS includes stimulation of five senses: gustatory (taste), visual (sight), tactile (touch), auditory (sound) and olfactory (smell). It is performed by giving a sweet taste, looking at baby’s face, massaging gently, talking quietly, and giving perfume to the nurse’s hand. In this study glucose/sucrose is replaced with breast milk because it is safe and provides a calming effect from its aroma for a long period, making it useable as smell stimulation. The aim of this study is to compare the effects of different multisensory methods using sucrose and breast milk on babies’ pain when undergoing blood sampling.

Who can participate?
2 to 28 day old babies admitted to the neonatal ward and undergoing peripheral blood sampling procedure

What does the study involve?
The babies are randomly allocated into three groups to receive multisensory stimulation with sucrose, multisensory stimulation with breast milk, or sucrose without multisensory stimulation, and their pain is measured when undergoing the blood sampling procedure.

What are the possible benefits and risks of participating?
The benefit of participating is the baby undergoing blood sampling can get treatment for relieving pain. No risks are expected as the treatment is standard procedure in some hospitals.

Where is the study run from?
Two general hospitals in West Java province in Indonesia

When is the study starting and how long is it expected to run for?
January 2017 to December 2018

Who is funding the study?
Ministry of Research, Technology and Higher Education (Indonesia)

Who is the main contact?
Mrs Siti Yuyun Rahayu Fitri

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Siti Yuyun Rahayu Fitri

ORCID ID

http://orcid.org/0000-0002-4816-9935

Contact details

Jl Tulip III No 8 Bumi Rancaekek Kencana
Rancaekek
Bandung
40394
Indonesia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multisensory stimulation as an effort to reduce pain Intensity in neonates

Acronym

Study hypothesis

1. Analgesia methods of multisensory stimulation using breast milk is no different to multisensory stimulation using sucrose in regard to its effect on pain intensity in neonates
2. Multisensory stimulation using breast milk is better than using sucrose as an analgesia method
3. Analgesia method of multisensory stimulation using sucrose is better than analgesia method using only sucrose regarding pain intensity in neonates

Ethics approval

Medical and health research ethics committee (MHREC) Faculty of Medicine Universitas Gadjah Mada Yogyakarta Indonesia, Gedung Radiopoetro Lt 2 Sayap Barat, Jl. Farmako, Sekip Utara, Yogyakarta, Indonesia 55128, Tel: 0274 588688 pswt 17225 , +62811-2666-869, Email: mhrec_fmugm@ugm.ac.id, No. KE/FK/1193/EC/2017

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

2 to 28 days old babies admitted to neonatal ward who underwent peripheral blood sampling procedure

Intervention

Randomisation with a block randomisation method to 3 interventions:

Multisensory stimulation (modification of sensorial saturation/SS):

1. SS analgesia methods of modified breast milk (test group):
- Prepare 1 cc syringe and 1 cc of breast milk
- Start talking to the baby 30 seconds before blood sample collection
- Gently massage baby’s face
- Bring the breast milk closer to baby’s nose
- Give breast milk until the baby sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Continue gentle massage and speak to the baby until the end of the procedure
- Measure pain intensity using PIPP-R instrument

2. Standard SS analgesia method (reference group):
- Prepare a vial of sucrose 24 %
- Start talking to the baby 30 seconds before blood sample collection
- Gently massage the baby’s face
- Give sucrose 24 % until he/she sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Continue gentle massage and talking to the baby until the end of the procedure
- Measure pain intensity using PIPP-R instrument

3. Sucrose 24% analgesia method (control group):
- Prepare the baby for blood sample collection
- Prepare a vial of sucrose 24%
- Give sucrose 24 % until he/she sucks rhythmically
- Perform blood sample collection while doing those maneuvers
- Measure pain intensity using PIPP-R instrument

Intervention type

Other

Phase

Drug names

Primary outcome measure

Pain intensity measured using PIPP-R (Premature Infant Pain Profile-Revised) at a single timepoint

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2017

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Baby undergoing peripheral blood sampling procedure
2. Minimum APGAR Score of 9 at 5 minutes
3. Gestational age > 32 weeks
4. Postnatal age of 48 hours
5. Sucking and swallowing reflex (+)
6. On treatment for less than 7 days
7. Received breast milk from mother

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

108

Participant exclusion criteria

Neonates who were given analgesic and sedative drug

Recruitment start date

12/04/2018

Recruitment end date

03/08/2018

Locations

Countries of recruitment

Indonesia

Trial participating centre

Universitas Gadjah Mada
Doctoral program faculty of medicine, public health and nursing Jl. Farmako, Senolowo, Sekip Utara, Sleman
Yogyakarta
55281
Indonesia

Sponsor information

Organisation

Universitas Gadjah Mada

Sponsor details

Faculty of medicine
public health and nursing
Jl. Farmako
Senolowo Sekip Utara
Yogyakarta
55281
Indonesia

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Indonesia

Results and Publications

Publication and dissemination plan

Planned publication in BMC Nursing

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Siti Yuyun Rahayu Fitri

Intention to publish date

01/03/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes