Massage to reduce bilirubin in newborns

ISRCTN	ISRCTN12080436
DOI	https://doi.org/10.1186/ISRCTN12080436
Secondary identifying numbers	R-2021-1002-04

Submission date: 23/03/2025
Registration date: 25/03/2025
Last edited: 25/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Yellowing of the skin and mucous membranes (jaundice) is a very common problem and can cause brain damage in babies. It has been reported that Vimala massage can help reduce this.

Who can participate?
All newborns aged 34 to 36.6 SDG according to the Ballard Scale hospitalized for yellowing of the skin and receiving light treatment to reduce the yellow coloration.

What does the study involve?
Participants are randomly allocated to the Vimala massage group (applied by the mothers twice a day for 3 consecutive days) or the control group (standard care). Serum bilirubin, number of stools, phototherapy requirement, and hospital stay were compared between the groups.

What are the potential benefits and risks of participating?
The possible benefits are the Vimala massage will reduce the time of light treatment and therefore the number of days of hospitalization.

Where is the study being conducted?
IMSS UMAE Hospital No. 48 in León (Mexico)

When does the study begin and how long is it expected to last?
June 2021 to February 2023

Who is funding the study?
Mexican Social Security Institute (Mexico)

Who is the primary contact?
Dr Alma Patricia González, alma.gonzalezx@imss.gob.mx

Study website

Contact information

Dr Alma Patricia Gonzalez
Public, Scientific, Principal Investigator

Av. Mexico e Insurgentes
Leon
37296
Mexico

ORCID ID	0000-0002-3401-7519
Phone	+52 (0)4771329126
Email	alma.gonzalezx@imss.gob.mx

Study information

Study design	Single-blind randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effect of Vimala massage on serum bilirubin levels in late preterm newborns with neonatal jaundice: a randomized clinical trial
Study acronym	MAVIHY
Study objectives	Vimala massage in conjunction with phototherapy reduces bilirubin levels in late premature newborns.
Ethics approval(s)	Approved 16/07/2021, Ethics Committee for Health Research 1028 (Av. Mexico e Insurgentes S/N , Col. Los Paraísos, León Guanajuato, 37328, Mexico; +52 (0)4771329126; 10028hgp48@gmail.com), ref: R-2021-1002-04
Health condition(s) or problem(s) studied	Hyperbilirubinemia in late premature newborns
Intervention	Randomization was done by random numbers in the Vassar Stata program. Late preterm infants 34 to 36.6 weeks of gestation with hyperbilirubinemia and treatment with phototherapy were randomized to the Vimala massage group (applied by the mothers twice a day for 3 consecutive days) or the control group (standard care). Both groups received phototherapy and standard newborn care measures, with the study group additionally receiving Vimala massage. The mothers of the newborn were trained prior to the first day of the study in the Vimala massage technique by one of the experienced researchers and it was applied following the technique and methodology of Vimala McClure at AIM (International Association of Infant Massage). A mannequin was used where the researcher showed the mothers through simulation how to perform the massage and it was reinforced with the explanation with drawings of the massage step by step. A checklist was made at the end of the demonstration to verify learning and when 80% approval of the list was reached, it was taken as learned. The mothers gave the massage with moderate pressure for a duration of 15 to 20 min according to the acceptance of the newborn and twice a day during visiting hours (at 12:00 and 18:00). The massage was performed in two phases. During the first phase, the patient was placed in a supine position and the massage was applied: following this order: 1. Face: gently massage the forehead with the thumbs outward, from the nose to the cheeks; they ran their thumbs from the upper lip to the cheeks, then under the ears with the index and middle fingers from the ears to the chin 2. Arms and hands: gently massage the armpit with circular movements; they slid their hands from the shoulder to the wrists; they used twisting motions in the opposite direction, gently rotating each finger for a circular massage on the back of the hands. In addition, slide your hands from wrist to shoulder with twisting motions on arms and forearms 3. Chest: both hands slid starting from the midline to the sides, from the sides to the midline, then from the midline to the right shoulder and back to the midline, then from the midline to the left shoulder and back to the midline. Extend both arms and cross over the chest 4. Abdomen: (“I love you”), the massage was performed from the location of the upper left abdomen to the right below the ribs downwards, and then it starts from the upper right abdomen exactly below the ribs to its opposite point, then downwards, perpendicular to the abdomen and alternating both hands like a "cogwheel" 5. Legs and feet: hands slid from thigh to ankle, twisting in opposite directions over thigh, leg, and foot; twist each toe; dorsiflexion of the sole of the foot and dorsum of the foot; circular movements in ankles; slide hands from ankle to thigh in upward motions. Second stage: the child was placed face down. Both hands slid from the back of the neck to the hips from top to bottom. They slid their hands from side to side in opposite directions; with the index and middle fingers they drew circles from top to bottom following the spine. They slid their fingertips from her head to her hips, up and down as if she were combing her hair.
Intervention type	Behavioural
Primary outcome measure	Serum bilirubin was measured on a 0.5 ml blood sample drawn from the dorsal plexus of the hand preferably, at 6:00 a.m. during the 3 days of the study. Bilirubin was measured with non-enzymatic methods using the chemical reaction that uses nitrous oxide to form a colour complex. Total serum bilirubin was determined by adding caffeine benzoate and diazo reagent in the same way as direct bilirubin. Finally, indirect bilirubin was calculated by subtracting total bilirubin minus direct bilirubin.at baseline and on the third day of treatment.
Secondary outcome measures	1. The number of stools quantified daily by the nursing staff during the 3 days of the study: number of evacuations obtained by the nurse on each shift and recorded on the corresponding vital signs and fluid balance control sheet 2. The number of days of need for phototherapy, considered according to the NICE Guidelines for hyperbilirubinemia 3. The length of hospital stay, including the number of days of hospitalization
Overall study start date	01/06/2021
Completion date	28/02/2023

Eligibility

Participant type(s)	Patient
Age group	Neonate
Lower age limit	1 Day
Upper age limit	6 Days
Sex	Both
Target number of participants	-
Total final enrolment	86
Key inclusion criteria	1. Preterm newborns of 34 to 36.6 weeks of gestation were included according to the Ballard scale 2. On phototherapy for indirect hyperbilirubinemia according to the NICE jaundice guidelines 3. Mother willing to apply the Vimala massage
Key exclusion criteria	Neonates with a diagnosis of isoimmunization, inborn errors of metabolism, dehydration or hemodynamic instability or with a mother who withdrew from participating
Date of first enrolment	20/07/2021
Date of final enrolment	20/02/2023

Locations

Countries of recruitment

Mexico

Study participating centre

Unidad Médica de Alta Esecialidaad HGP No 48 IMSS

Av. Mexico e Insurgentes s/N, col. Los paraísos
León Guanajuato
37328
Mexico

Sponsor information

Mexican Social Security Institute
Government

Av. Mexico e Insurgentes
León Guanajuato
37296
Mexico

Phone	+52 (0)4771329126
Email	patipili999@hotmail.com
Website	https://sirelcis.imss.gob.mx/acceso
"ROR"	https://ror.org/03xddgg98

Funders

Funder type

Government

Instituto Mexicano del Seguro Social
Government organisation / National government

Alternative name(s): Mexican Social Security Institute, IMSS
Location: Mexico

Results and Publications

Intention to publish date	30/03/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	It will be disseminated through the publication of a scientific article in an indexed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Dra A. Patricia González (alma.gonzalezx@imss.gob.mx)

Editorial Notes

25/03/2025: Study's existence confirmed by the Ethics Committee for Health Research.