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Clinical Trials/NCT04037202
NCT04037202CompletedNot Applicable

Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial

Ege University1 site in 1 country66 target enrollmentStarted: July 3, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Informed Consent Form

Study Overview

Brief Summary

Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

Detailed Description

Background and purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.

Materials and methods

In order to keep the number of people in balance between the groups, "block randomization" method which is one of the fixed probability randomization types was preferred. The research was completed with 66 persons, 33 in the study group and 33 in the control group. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.

Research inclusion criteria include (i) primipara mothers (who had their first birth), (ii) mothers who had normal vaginal delivery, (iii) those who had undergone episiotomy, (iv) who were volunteered to participate in the study, (v) who were on the first day of delivery (first 24 hours), (vi) who had no complications in the infant and the baby, (vii) age of whom ranged from 18 to 35, (viii) those who did not apply or receive any other complementary therapy, (ix) mothers who did not have any wound, infection or discomfort etc. on their feet, and those who can read and write.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •primipara mothers (who had their first birth),
  • •mothers who had normal vaginal delivery,
  • •those who had undergone episiotomy,
  • •who were volunteered to participate in the study,
  • •who were on the first day of delivery (first 24 hours),
  • •who had no complications in the infant and the baby,
  • •age of whom ranged from 18 to 35,
  • •those who did not apply or receive any other complementary therapy,
  • •mothers who did not have any wound, infection or discomfort etc. on their feet,
  • •mothers who can read and write

Exclusion Criteria

  • •mothers with any systemic disease
  • •mothers who dislike foot massage during practice
  • •early discharge mothers
  • •mothers who applied another massage technique
  • •mothers who take the analgesic drug unnecessarily

Arms & Interventions

Study Group

Experimental

The first session of the foot massage was performed after mothers were taken to the postpartum service and after the effect of the first analgesia had elapsed (4-6 hours after birth).

The researcher prepared the mother for foot massage (foot care, proper position, etc.) and gave a total of 20-minute massage of foot massage, 10 minutes for each foot. VAS was repeated immediately after the first session (in the 20th minute) and after 30 minutes (in the 50th minute). The second session was performed on the second day, 20-24 hours after the first session (before the discharge). The VAS was analyzed before the second (last) session (0th minute), and the VAS was repeated immediately after the application (20th minute) and 30 minutes (50th minute), and the PCS was administered for the last time. Administered analgesics were recorded in the DFC and the administration made with package leaflet was supported.

Intervention: Foot massage (Other)

Control Group

No Intervention

Routine procedures were applied and VAS was repeated at the same time periodical as the study group mothers (0th, 20th and 50th minute) and after 20-24 hours (before discharge), at the same time intervals (0th, 20th and 50th minute) pain status was measured by using VAS and PCS was administered for the last time and analgesics administered were recorded on the DFC.

Outcomes

Primary Outcomes

Informed Consent Form

Time Frame: 5-10 minutes

The form consists of 31 questions about family, pregnancy, birth and newborn characteristics.This form was completed during the first meeting at the hospital.

Postpartum Comfort Scale (PCS)

Time Frame: 5-10 minutes

In accordance with the comfort theory developed by Katharine Kolcaba in 1994, the PCS developed by Karakaplan and Yıldız (2010) consists of 34 items.A 5-point Likert-type scoring system was used to evaluate each item.Expression and scoring were made for each item ranging from "totally agree" (5 points), and "strongly disagree" (1 points).In positive sentences, "I fully agree" indicates the best comfort (5 points) and in negative sentences low comfort (1 points).Accordingly, the lowest score to be taken from the scale is 34 and the highest score is 170.

Visual Analog Scale (VAS)

Time Frame: Less than 1 minute

It is a single-item continuous scale consisting of a horizontal or vertical line and is usually 10 centimeters (100 mm) in length. For example, the severity of pain a patient feels ranges from "no pain" with 0 points on a line to "severe pain" with 10 points.Scoring is achieved by measuring the point the patient has marked with a ruler.Pain relief points in VAS; * Absence of pain (0-4 mm), * Slight pain (5-44 mm), * Moderate pain (45-74 mm) * Severe pain (75-100 mm)

Drug Follow-up Card (DFC)

Time Frame: About 1 minute

The researcher was prepared, this is a follow-up card in which the name and surname of the mothers, the name of the drug given to the mothers, the route of administration of the drug, date / time and dosage are indicated.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rabia Genç

Associate Professor

Ege University

Study Sites (1)

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