Non-Pharmacological Method to Relieve Back Pain

NCT05893355 | Completed

• 1 other identifier: sdilek4
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be carried out in a randomized controlled manner in order to examine the effectiveness of acupressure applied in the late postpartum period in postpartum women who have had back pain and have had a cesarean delivery. The sample of the study will consist of 70 participants who applied to the family health center between 05.06.2023 and 05.12.2024, who had cesarean birth registered in the central family health center in Kocaeli province Kandıra district, who met the research criteria and agreed to participate in the research. Data in the research; It will be collected using the 'Participant Information Form', 'VAS (Visual Analog Scale for Evaluating Back Pain)', 'McGill Pain Questionnaire (Short Form)'. Participants in the acupressure group will be given 2 times acupressure application in the 1st week and 4th week postpartum. No application will be made to the participants in the control group. The research is planned to be carried out after obtaining the necessary institutional and ethical committee permissions.

Conditions

Pain

Keywords

Back Pain; Late postpartum; Cesarean Section

Outcome Measures

Primary Outcomes (2)

• Visual analog scale for assessing back pain

  The application will be made at the end of the first week after birth. The participant 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 participant 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 filled by the participants before the application is made at the end of the first week after birth.

• Visual analog scale for assessing back pain

  The application will be made at the end of the first week after birth. The participant 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 participant 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 filled in by the participants after the application is made at the end of the first week after birth.

Secondary Outcomes (2)

• Visual analog scale for assessing back pain

  This scale will be filled by the participants before the application is made at the end of the first mounth after birth.

• Visual analog scale for assessing back pain

  This scale will be filled in by the participants after the application at the end of the first mounth after birth.

Study Arms (2)

Acupressure group

EXPERIMENTAL

* Participants in this group will be interviewed for the first time in the first week of postpartum and for the second time in the fourth week of postpartum. The application will be explained and a voluntary consent form will be signed. * Participant Information Form will be filled in by the researcher by face-to-face interview. * The VAS that will be applied to the participant to evaluate the back pain just before the application will be filled in by the participant. * The VAS Evaluating Back Pain after the application will be filled in by the participant. * The participant will be informed that the study has been completed.

Behavioral: Acupressure group

Control group

NO INTERVENTION

* Participants in this group will be interviewed for the first time in the first week of postpartum and for the second time in the fourth week of postpartum. The application will be explained and a voluntary consent form will be signed. * Participant Information Form will be filled in by the researcher by face-to-face interview. * VAS to assess back pain will be filled in by the participant. * No application will be made to this group.

Interventions

Acupressure group BEHAVIORAL

Application to Acupressure Group * Participants in this group will be interviewed for the first time at postpartum week 1, and for the second time between 4-6 weeks postpartum. The application will be explained and a voluntary consent form will be signed. * Participant Information Form will be filled in by the researcher by face-to-face interview. * The VAS, which will be applied to the puerperant women for the first time in the first week of the postpartum week and for the second time between the 4th-6th weeks, will be filled by the participant just before the application to evaluate the back pain. * The VAS Evaluating Back Pain after the application will be filled in by the participant. * The participant will be informed that the study has been completed.

Acupressure group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• Able to read and write Turkish
• Postpartum 1st week and within 4th week
• Primiparous and multiparous
• Those who had a registered cesarean section in the family health center where the study was conducted,
• Able to speak and understand Turkish,
• Back pain score above 4 according to VAS (Visual analog scale),
• Participants who voluntarily agree to participate in the study will be included in the study.

You may not qualify if:

• Congenital anomaly in the baby who gave a stillbirth, whose baby is hospitalized in the neonatal intensive care unit,
• Use of cigarettes or alcohol
• History of past or present mental illness,
• Using antidepressants or anxiolytic drugs,
• With rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, Ehlers-Danlos syndrome, spinal surgeries, nerve root compression, spondylolisthesis comorbid disease,
• Perineal edema, hematoma, wound dehiscence, bladder catheterization and serious postpartum complications (internal bleeding, femoral artery embolism, pelvic fracture),
• With impaired tissue integrity in the area to be applied,
• Vaginal delivery,
• Taking painkillers in the last 6 hours,
• 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

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mukerrem Sisman, Midwife

  Kocaeli Kandıra Family Health Center

  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: May 30, 2023
• First Posted: June 7, 2023
• Study Start: June 5, 2023
• Primary Completion: October 25, 2023
• Study Completion: December 13, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)