The Effect of Newborn Massage on Comfort Level and Vital Signs

NCT ID: NCT06529263

Last Updated: 2024-07-31

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-09-15

Brief Summary

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This study was planned as a randomized, controlled, experimental study to examine the effect of neonatal massage on the comfort level and vital signs of newborn babies.An answer to the question "Does massage applied to infants in the neonatal period have an effect on vital signs and comfort level?" will be sought.

Detailed Description

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The sample of the study consisted of a total of 60 infants, 30 in the experimental group and 30 in the control group, who were hospitalized in the Neonatal Intensive Care Unit of a City Hospital between December 2022 and April 2023, whose parents' written and verbal consent was obtained for participation in the study after being informed, and who met the inclusion criteria. "Data Collection Form", 'Life Findings Assessment Form' and 'Newborn Comfort Behaviors Scale' prepared by the researchers were used as data collection tools. Newborns in the experimental group were massaged twice a day for 15 minutes 30 minutes after feeding and routine care for 4 days. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.

Conditions

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Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled experimental study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Massage group

is the newborn massage group.The experimental group was massaged twice a day for 15 minutes 30 minutes after feeding and routine care for 4 days.

Group Type EXPERIMENTAL

newborn massage

Intervention Type OTHER

Newborn massage is one of the complementary treatment methods that support the treatment and contribute to the development of the baby

Control group

is the group without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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newborn massage

Newborn massage is one of the complementary treatment methods that support the treatment and contribute to the development of the baby

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age between 37-42 weeks,
* Birth weight of 2500 grams and above,
* The infant was hospitalized in the Neonatal Intensive Care Unit during data collection,
* Completion of 24 hours after birth

Exclusion Criteria

* Gestational age below 37 weeks,
* Birth weight below 2500 grams,
* Refusal of the parent to participate in the study,
* The baby is on mechanical ventilation
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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aysel kokcudogan

Ph.D., Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysel Kokcu Dogan

Role: STUDY_DIRECTOR

Faculty Member

Locations

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Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-10840098-772.02-7436

Identifier Type: -

Identifier Source: org_study_id

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