Nonpharmacological Method for Relief of Uterine Pain

NCT05424861 | Completed

• 1 other identifier: sdilek1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum uterine pain is an important part of the postpartum period and is a concern for women, which can negatively affect maternal-neonatal attachment and breastfeeding. Acupressure allows midwives to make evidence-based independent practice in controlling postpartum uterine pain. The aim of this study is to determine the effectiveness of acupressure, which is a non-pharmacological intervention, for postpartum uterine pain after vaginal delivery. The research will be carried out between February 2022 and December 2022 with mothers who gave vaginal birth at Health Sciences University Kocaeli Derince Training and Research Hospital. The research will be carried out with two groups as acupressure and control groups. The sample number was calculated using the G\*Power 3.1.9.2 program and the acupressure group: 61 and the control group: 61. It was planned to collect the research data with the Introductory Information Form and Visual Analog Scale in which Postpartum Uterine Pain was evaluated. Postpartum 6-24 days in the acupressure group. Acupressure will be applied once between hours, just before breastfeeding. The visual analog scale, in which the introductory information form is filled by the researcher and the pain score is evaluated, will be marked by the participant once before breastfeeding, once at the 10th minute of breastfeeding, and once at the 20th minute, in total 3 times. No application will be made to the control group. The data of the research will be evaluated using the Statistical Package 22.0 program for Social Sciences. In the evaluation of the data; descriptive statistics will be given as percentage, arithmetic mean±standard deviation, median and minimum-maximum values. Independent two-sample t-test will be used for normally distributed variables and Mann-Whitney U test will be used for non-normally distributed variables. Pearson Correlation test will be applied to determine the relationship between the pain intensity of the acupressure group and the tests and to determine the relationship between the tests. Statistical significance level will be accepted as p\<0.05.

Conditions

Pain

Keywords

Pain; involution; breast-feeding

Outcome Measures

Primary Outcomes (3)

• Visual analog scale for assessing postpartum uterine pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

  This scale will be completed by the participants just before breastfeeding.

• Visual analog scale for assessing postpartum uterine pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

  This scale will be completed by the participants at the 10th minute of breastfeeding.

• Visual analog scale for assessing postpartum uterine pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that VAS is more sensitive and reliable than other unidimensional scales in pain severity measurement. The VAS is more sensitive than the simple descriptive scale.

  This scale will be completed by the participants at the 20th minute of breastfeeding.

Study Arms (2)

Acupressure group

ACTIVE COMPARATOR

Postpartum 6-24 days in the acupressure group. Acupressure will be applied 1 time just before breastfeeding between hours. The visual analog scale, in which the introductory information form is filled by the researcher and the pain score is evaluated, will be marked by the participant once before breastfeeding, once at the 10th minute of breastfeeding, and once at the 20th minute, in total 3 times.

Behavioral: Acupressure group

Control group

ACTIVE COMPARATOR

Postpartum 6-24 days in the control group. Introductory information form will be filled by the researcher between hours. The visual analog scale, in which the pain score is evaluated, will be marked by the participant for a total of 3 times, once just before breastfeeding, once at the 10th minute of breastfeeding, and once at the 20th minute.

Other: Control group

Interventions

Acupressure group BEHAVIORAL

A suitable environment will be prepared for mothers in terms of warmth and light, where privacy can be protected. The application points will be determined with the acu-point device by choosing the most comfortable position of the mother, leaving the application points open. The most preferred points LI4 and SP6 were selected among the points that were reported to be effective in relieving luterus pain by scanning the literature on the points to be compressed. Acupressure will be applied to the points (bidirectional, right and left) for 2 minutes, for a total of 8 minutes. Light pressure will be applied with the thumb of the practitioner's hand. Immediately after applying pressure for 2 minutes for each point, it is passed to the other point in the symmetrical region and the application is made without interruption. While practicing, the researcher will check the time using a digital wristwatch with a stopwatch.

Acupressure group

Control group OTHER

No application will be made. The mothers in this group will fill in the visual analog scale, which evaluates postpartum uterine pain 3 times between 6-24 hours after birth.

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having a single and live baby between 37-42 weeks of gestation,
• Normal spontaneous vaginal delivery,
• Multiparous,
• Having a baby weighing 2-4 kilograms,
• No general anesthetic agent was used at birth,
• Have not used a non-pharmacological method for pain before,
• Having a Visual Analogue Scale (VAS) score of 4 and above for uterine pain before breastfeeding,
• Not having breastfeeding problems,
• Not having any health problems (Tuberculosis, HIV, cancer, etc.),
• Having given birth at least 6 hours ago,
• Does not have any problems preventing communication,
• Able to read and write,
• Able to speak and understand Turkish,
• Volunteer mothers who agreed to participate in the study will be included.

You may not qualify if:

• Having a situation that prevents breastfeeding (galactosemia, congenital anomalies, etc.),
• Having postpartum complications (bleeding, infection, etc.),
• Separated from her baby for any reason after birth (in cases where the mother or baby is referred, hospitalized in intensive care or isolated),
• Having lost her baby,
• Having any complications during pregnancy (gestational diabetes, preeclampsia, Rh incompatibility, heart disease, etc.),
• With uterine anomaly,
• Tissue integrity deteriorated in the area to be treated,
• Taking painkillers in the last 6 hours,
• Smoking or using alcohol,
• Those with positive Covid-19 test will be excluded from the study. In addition, those who want to leave the research at any stage of the research will be excluded from the research.

Sponsors & Collaborators

• Kocaeli University: lead
• Medipol University: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sena Dilek Aksoy, Ph.D

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Resmiye Kaya Odabas, MSc

  Kocaeli University

  STUDY CHAIR

• Derya Kanza Gul, MD

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: June 16, 2022
• Primary Completion: August 26, 2022
• Study Completion: November 24, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)