Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight

March 8, 2024 updated by: Ahmed Ali Mohammed Torad, Kafrelsheikh University
Effect of massage on hormone levels in puerperal women

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafrelshiekh, Egypt, 6850001
        • Kafrelshiekh university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • puerperal women within 4 hours of normal delivery and they are primiparous

Exclusion Criteria:

  • nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Postpartum Back Massage is done to puerperal women just after 4 hours of delivery and for 1 month with rate of 3 sessions per week and routine postnatal care
Other: Postpartum back massage in study group
Effleurage massage from shoulders toward lower back
No Intervention: Control group
Puerperal women just have routine post natal care for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leptin and prolactin levels increase
Time Frame: 1 month
Increase levels of lactating hormones
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Information will be releasid on pub med

IPD Sharing Time Frame

June 2024 to june 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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