The Effect of Controlled Massage Applied at Birth on Labor Pain and Duration and Maternal Satisfaction

NCT05237765 | Completed

• 1 other identifier: TarsusU
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This study was carried out to determine the effect of controlled massage applied at birth on labor pain and duration and maternal satisfaction. The study was conducted as a randomized, controlled research. The research was conducted with 154 randomized pregnant women admitted to Erzurum Nenehatun Obstetrics and Maternity hospital between February-November 2019. The study consisted of 3 different groups: Group A included the pregnant women who received routine hospital care (control group n=53), Group B included the pregnant women who received midwife-controlled massage (n=50), and the Group C consisted of the pregnant women who received self-controlled massage (n=51). It was determined that the controlled massage intervention that was applied in this study reduced labor pain, but it did not affect the duration of labor or the satisfaction levels of the women.

Conditions

Massage

Keywords

Birth, labor duration, labor pain, massage, satisfaction

Outcome Measures

Primary Outcomes (6)

• Personal Information Form

  This was a form that was prepared to collect information on the sociodemographic and obstetric characteristics of the participants. The form was filled when the pregnant woman was admitted to the labor room.

  Delivery (when pregnant women come to the delivery room)

• Visual Analogue Scale (VAS)

  The participants marked the levels of pain they perceived at the end of the latent, active and transitional phases of labor on a 10-cm ruler whose two extreme points represented "no pain at all" and "unbearable pain". This is a sensitive and reliable scale in the measurement of pain severity.

  Latent, active and transition phase in labor

• Verbal Category Scale (VCS)

  This is a one-dimensional, easy-to-apply and descriptive scale. The participants were asked to select one of the phrases "mild, uncomfortable, severe, highly severe, unbearable" that represented their pain status best.

  Latent, active and transition phase of labor

• Partograph

  It is a graphical form that is used starting with the active phase of labor and allows the detailed monitoring of the labor process and early detection of abnormal events. It was used in this study to determine the duration of labor based on its phases and the effect of the massage intervention on this duration.

  active and transition phase of labor

• Individual-Controlled Massage Follow-Up Form (ICMFF)

  ICMFF was a form that was developed by the researcher on which the active and transitional phases of labor were marked, and the duration and intensity of the massage that was applied were recorded by specifying the exact times. It was filled out by the researcher at the end of each massage application.

  active and transition phase of labor

• Scale for Maternal Satisfaction in Vaginal Delivery (SMSVD)

  This scale determines the satisfaction levels of mothers regarding the care they have received at the hospital in normal vaginal labor. It is a 5-point Likert-type (1: absolutely disagree to 5: absolutely agree) scale consisting of 43 items and 10 dimensions. Thirteen items in the scale are inversely scored. The scores of these 13 items are reversed while calculating the total score of the scale. Higher total scores indicate higher levels of maternal satisfaction from the care received at the hospital in the normal vaginal labor process. The cutoff point calculated for SMSVD is 150.5, where scores higher than 150.5 indicate high satisfaction levels, and those lower than 150.5 indicate low satisfaction levels. The form was applied by the researcher in the fourth phase of labor, when the mother was taken to her bed. The authors who developed the scale determined its Cronbach's alpha internal consistency coefficient as 0.91.

  within a period of 1-4 hours postpartum

Study Arms (3)

midwife-controlled massage

EXPERIMENTAL

Other: controlled (automatic) massage

self-controlled massage

EXPERIMENTAL

Other: controlled (automatic) massage

control group

NO INTERVENTION

Interventions

controlled (automatic) massage OTHER

Massage methods that are performed with mechanical methods are called automated massage. Automated massage is also individual-controlled massage. This is because in automated massage, to relax, solve or reduce their pain, the individual applies the massage under their own control or under the control of someone else through a controller in a way where the duration and intensity of the massage in the body part of application vary. Individual-controlled massage devices may be in the form of chairs, cushions, beds and mattresses. These massage devices have functions such as vibrating, applying vacuum, imitating manual massage motions and applying heat.

midwife-controlled massage; self-controlled massage

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having at least a primary school degree
• Not having a communication problem
• Having a primiparous term pregnancy (38-42 weeks)
• Not having an obstetric risk
• Being in the latent phase of labor (dilation 0-3cm)
• Having no contraindications for massage

You may not qualify if:

• Being multiparous
• Having a high-risk pregnancy
• Being in the active or transitional phase of labor
• Having a contraindication to massage

Sponsors & Collaborators

• Tarsus University: lead
• Ataturk University: collaborator

Study Sites (1)

Tarsus University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Personal Satisfaction

Interventions

Control Groups; Massage

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gülüzar Sade, Dr.

  Tarsus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Assistant Professor

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 14, 2022
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 29, 2020
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

TU (1)