Effect of Kangaroo Baby Massage on Mother-infant Interaction at Home

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2021-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Kangaroo Holding and Maternal Stress

NCT00271115

Premature Birth Maternal Stress

COMPLETED NA

Concept Map on Toxic Stress in Newborns

NCT06418815

Nursing Education Newborn

NOT_YET_RECRUITING NA

Massage Application and Motor Performance, Stress Assessment in Premature Babies

NCT06075992

Infant Premature Birth

UNKNOWN NA

Effect of Maternal Odor and Kangaroo Care on Serum Cortisol and Comfort Levels in Preterm Infants: a Randomised Trial

NCT05607706

Preterm Birth Complication Stress Related Disorder Cortisol Overproduction

COMPLETED NA

EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT

NCT05903872

LACTATION IN MOTHERS WITH PREMATURE NEWBORNS

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.

Barnard's mother-child interaction theory supports the study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Low Birth Weight Mother-Infant Interaction Gain, Weight Depression, Post-Partum Breastfeeding Feeding, Breast

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two interventions groups of 34 each, participated in the study. The first group received Nursing intervention Kangaroo Baby Massage KBM at home and the second group received Kangaroo position KP at home, the KBM will start when the infant arrives at home until they leave the kangaroo position. The KP will measure since the baby arrive at home until leave the kangaroo position.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The infant-mother dyads will not be Know that there are two different interventions in each group. This leads to greater adherence to treatment.

The researchers: there will be two research assistants who will receive capacity regardless of the group of participants they are going to train, the main researcher will not carry out the training to the mothers and will be blinded.

The nursing assistant in charge of weighing the baby and the pediatrician who determines the time of the kangaroo position. They will be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kangaroo baby Massage

The mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed.

Group Type EXPERIMENTAL

Kangaroo Baby Massage

Intervention Type BEHAVIORAL

The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video

Kangaroo position

The infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature.

Group Type ACTIVE_COMPARATOR

Kangaroo Baby Massage

Intervention Type BEHAVIORAL

The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kangaroo Baby Massage

The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Masaje al Bebé Canguro Nursing intervention KBM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
* The mothers take care the infant at home
* Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
* Baby whose birth was institutional or extra-institutional.
* Mothers with training in the Kangaroo Mother Program
* Children controlled in the Ambulatory Kangaroo Mother Program

Exclusion Criteria

* Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
* Children who have more than one ambulatory kangaroo control
* Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
* Babies with infections and other pathologies that require hospitalization during the study
* Presence of infectious diseases and other pathologies in the mother that require hospitalization
* Mother confirmed with positive test for covid 19 at the moment of the randomization
* Mothers with cognitive problems or mental disorders.

Minimum Eligible Age

2 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No