Endorphin Massage Application to Women Who Gave Birth Vaginally

NCT05764512 | Completed

• 1 other identifier: 2023/09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.

Conditions

Pain; Birth, First

Keywords

Birth; Vaginal Birth; Massage; Pain; Endorphin

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  It is a commonly used scale to measure pain. It consists of a 10 cm ruler on which the patient marks the pain, showing that there is no pain at one end and unbearable pain at the other end. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded. In addition, this scale is used to measure comfort. The VAS, which will be used to determine the level of comfort, consists of a ruler of 0 to 10 cm, as well as the level of pain. VAS; 0 = very comfortable, 10 = extremely uncomfortable. In the calculation of the comfort score, the distance between the place marked by the puerperant as "I am comfortable" and the place marked as "I am uncomfortable" is measured and recorded in cm. In this research, the Visual Analog Scale is used to measure both pain level and comfort level.

  two hours

• Brief Mood Introspection Scale

  In the 16-item scale, the items consist of the emotion adjective and aim to evaluate the current emotional state of the participants. By obtaining two types of scores with the scale, positive (8 items) and negative (8 items) mood levels of the participants are determined. High scores for both mood states indicate high positive or negative emotions. The highest score for both moods is 32 and the lowest score is 8.

  two hours

• Serum Beta Endorphin Level

  Blood samples are taken from the puerperal women by following the antiseptic rules, into a yellow-capped and gelled blood tube (3-4 mL) by the researcher. The blood tubes are kept at room temperature and in an upright position for 30 minutes. Samples sent to the laboratory are centrifuged at 4000 rpm for 10 minutes. The serum obtained after centrifugation is taken from the blood tubes, put into eppendorf tubes and stored frozen at -80 degrees.

  two hours

Study Arms (2)

Intervention group

EXPERIMENTAL

Is the group to which endorphin massage will be applied. Endorphin massage is a gentle touch and massage method that can improve the relaxation state in the body through the skin surface.

Other: Endorphin massage

Control gruop

NO INTERVENTION

No application will be made.

Interventions

Endorphin massage OTHER

With the anterior surface of the fingertips of the hand, a "V" will be drawn slowly, starting from the sacral region and towards the ribs. The same process will be continued from the sacral region until the 7th cervical vertebra. From the 7th cervical vertebra, the front surface of the fingertips will be descended first to the shoulders and then to the dorsal region of the upper and forearms in turn. Starting from the dorsal region of the forearm, the first stage of the massage will end by descending to the upper arm, shoulders, 7th cervical vertebra, spine and sacral region with the back of the thumbs. These massage steps will be repeated until 20 minutes are completed. Endorphin massage will be applied every 2 hours.

Intervention group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Those who gave birth vaginally in their gestational week,
• In the first 24 hours postpartum,
• Primiparous,
• Episiotomy applied,
• Having a VAS value of at least 5 points,
• Having given birth to a single baby,
• Your baby's APGAR Score is between 7-10,
• Skin-tissue integrity,
• No communication problem,
• The spoken language is Turkish,
• Voluntary to participate in the study

You may not qualify if:

• The baby was admitted to the neonatal intensive care unit,
• Having a cesarean section,
• Experiencing risky labor,
• Postpartum bleeding,
• Epidural analgesia applied
• Having a psychiatric disease (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
• Having chronic disease (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD),
• Postpartum women diagnosed with risky pregnancy (Pre-eclampsia, Eclampsi, Pregnancy-related hypertension, Gestational diabetes, bleeding conditions during pregnancy)

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Kayseri City Hospital

Kocasinan, Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

• Guney E, Ucar T. Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101320. doi: 10.1016/j.ctcp.2021.101320. Epub 2021 Jan 28.

  PMID: 33548749 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nurseli SOYLU ERENER

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The blood samples are numbered by writing the names of the puerperant women. Nurses who care, the biochemist who analyzes the blood samples and the specialist who does the statistical analysis will not know the groups to which the puerperal puerperants are assigned. In the hospital where the research will be conducted, one of the two parts of the postpartum service is used for the intervention group and the other for the control group in order to prevent encounters between the intervention and control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Two gruops with intervention gruop and control grup.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 10, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)