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Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth

Primary Purpose

Postpartum Disorder, Massage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Foot massage
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postpartum Disorder focused on measuring analgesia, massage, midwifery, pain, postpartum period

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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.

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 Outcome Measures

Informed Consent Form
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)
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)
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)
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 Outcome Measures

Full Information

First Posted
July 24, 2019
Last Updated
July 29, 2019
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04037202
Brief Title
Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth
Official Title
Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Disorder, Massage
Keywords
analgesia, massage, midwifery, pain, postpartum period

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Foot massage
Intervention Description
Foot massage includes classical massage techniques such as effleurage, petrissage and friction techniques. Effleurage is the movement of stroking and lubricating superficial tissues. Therefore, it is performed at the beginning and ending of the massage. Petrissage is the slow and rhythmic movement to apply direct pressure to the soft tissue underlying the skin with the balls of the fingers and thumbs. Friction is the application of pressure through small circular movements only in small areas, using hand or fingers. While muscle tissue is compressed and relaxed, blood and lymph circulation increases. Thus, lactic acid in the muscle fibers is diminished and fatigue and stress are decreased.
Primary Outcome Measure Information:
Title
Informed Consent Form
Description
The form consists of 31 questions about family, pregnancy, birth and newborn characteristics.This form was completed during the first meeting at the hospital.
Time Frame
5-10 minutes
Title
Postpartum Comfort Scale (PCS)
Description
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.
Time Frame
5-10 minutes
Title
Visual Analog Scale (VAS)
Description
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)
Time Frame
Less than 1 minute
Title
Drug Follow-up Card (DFC)
Description
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.
Time Frame
About 1 minute

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ege University
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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Links:
URL
http://www.diclemedj.org/upload/sayi/20/Dicle%20Med%20J-01507.pdf
Description
Factors that affecting mothers' postnatal comfort
URL
https://dergipark.org.tr/download/article-file/205618
Description
Effect of Uterine Massage in the Perception of Women's Postpartum Pain Intensity

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Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth

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