Nonpharmacological Method and Postpartum Fatigue

NCT05201157 | Completed

• 1 other identifier: Resmiye-02
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum fatigue is common in women after cesarean section and it affects the woman and the baby. Many noninvasive applications help to overcome this problem. This study was planned as a randomized controlled trial to examine the effect of acupressure on postpartum fatigue in women who had a cesarean section. The research will be carried out between August 2021 and August 2022 with mothers who have had a cesarean section at Kocaeli University Research and Application Hospital. The research will be carried out with two groups as acupressure and control group. The sample number was calculated using the G\*Power 3.1.9.2 program and the acupressure group: 60 and the control group: 60. In order to increase the analysis power, the number of people for each group was taken as 65 (n=130). It is planned to collect the data with the Descriptive Information Form and the Visual Similarity Scale for Fatigue. Acupressure will be applied to the mothers in the acupressure group once, once on the post-op day 0, twice on the post-op 1. day and once on the post-op 2. day, for a total of 4 times for six minutes, and no application will be made to the control group. Fatigue will be assessed with the Visual Similarity Scale for Fatigue before administration on post-op day 0 and after administration on post-op day 2. The data of the research will be evaluated using the Statistical Package for the Social Sciences 22.0 program. 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 for non-normally distributed variables. Pearson Correlation test will be applied to determine the relationship between the fatigue severity of the experimental group and the tests and to determine the relationship between the tests. Statistical significance level will be accepted as p\<0.05.

Conditions

Fatigue

Keywords

postpartum fatigue; postpartum; fatigue; acupressure

Outcome Measures

Primary Outcomes (2)

• Visual Similarity Scale for Fatigue

  The scale consists of 18 items, including fatigue (items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18) and energy (items 6, 7, 8, 9, 10). ) consists of two sub-dimensions. The scale consists of 10 cm horizontal lines with positive statements on one end and negative statements on the other. The lowest score obtained in the fatigue sub-dimension is 0, and the highest score is 130. In the energy sub-dimension, scores are calculated in the range of 0-50 points. The high score of the fatigue sub-dimension and the low score of the energy sub-dimension indicate that the severity of fatigue increases.

  This scale will be filled by mothers between 8-12 hours after cesarean section.

• Visual Similarity Scale for Fatigue

  The scale consists of 18 items, including fatigue (items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18) and energy (items 6, 7, 8, 9, 10). ) consists of two sub-dimensions. The scale consists of 10 cm horizontal lines with positive statements on one end and negative statements on the other. The lowest score obtained in the fatigue sub-dimension is 0, and the highest score is 130. In the energy sub-dimension, scores are calculated in the range of 0-50 points. The high score of the fatigue sub-dimension and the low score of the energy sub-dimension indicate that the severity of fatigue increases.

  This scale will be filled in by the mothers between in postoperative period on 2.days at 08.00-16:00 am]

Study Arms (2)

Acupressure group

ACTIVE COMPARATOR

Acupressure will be applied to ST36, LI4 and SP6 points.The Introductory Information Form will be filled in by the researcher and the Visual Similarity Scale for Fatigue will be filled by women once on the post-op 0th day and once on the post-op 2nd day, a total of 2 times.

Other: acupressure group

Control Group

ACTIVE COMPARATOR

No application will be made to this group, and the Introductory Information Form will be filled in by the researcher and the Visual Similarity Scale for Fatigue will be filled in 2 times in total, once on the post-op 0th day and once on the post-op 2nd day.

Other: Control Group

Interventions

acupressure group OTHER

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 exposed. The most preferred points ST36, LI4 and SP6 were selected from the points reported to affect lactation by reviewing the literature on the points to be compressed. Acupressure will be applied to points (bidirectional, right and left) for 2 minutes for a total of 6 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 will be moved to the other point in the symmetrical region and the application will be made without interruption. While practicing, the researcher will control the time using a digital wrist watch with a stopwatch

Acupressure group

Control Group OTHER

No application will be made. The mothers in this group will fill in the Visual Similarity Scale for Fatigue twice, once between 8-12 hours post-op and once on the post-op 2nd day.

Control Group

Eligibility Criteria

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

You may qualify if:

• Between the ages of 18-35,
• Birth after 36th gestational week,
• Multiparous
• Caesarean section with regional anesthesia,
• Mobilized,
• Not having any health problems (Hypertension, tuberculosis, HIV, cancer, psychological disorders, etc.),
• Does not have any problems preventing communication,
• At least primary school graduate,
• Able to speak and understand Turkish,
• Volunteer women who agreed to participate in the study

You may not qualify if:

• Having postpartum complications (bleeding, embolism, eclampsia, infection, etc.),
• Having a hemoglobin level of less than 9 g/dl and a hematocrit level of less than 30%,
• Having a body mass index of 40 and above,
• Covid-19 test positive,
• Having twin babies,
• The baby is in the neonatal intensive care unit,
• Having been diagnosed psychologically (such as depression) before,
• Women who do not want to participate in the research will be excluded from the study.

Sponsors & Collaborators

• resmiye kaya odabaş: lead

Study Sites (1)

Aydın Adnan Menderes University

Efeler, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Resmiye Kaya Odabaş, Ress. Ass.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Yasemin Sökmen, Instructor

  Ondokuz Mayıs University

  STUDY CHAIR

• Ayten Taşpınar, Prof Doctor

  Aydin Adnan Menderes 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: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: August 12, 2021
• Primary Completion: January 9, 2022
• Study Completion: March 13, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)