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临床试验/NCT04037202
NCT04037202已完成不适用

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

Ege University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Informed Consent Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

Informed Consent Form

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabia Genç

Associate Professor

Ege University

研究点 (1)

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