NCT06342154

Brief Summary

Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 22, 2024

Last Update Submit

March 28, 2024

Conditions

Keywords

endorphin massagecortisol levelstresspregnant women

Outcome Measures

Primary Outcomes (3)

  • visual analog scale (VAS)

    VAS is preferred to convert some values that cannot be measured numerically into numerical values. VAS, which is a simple, effective, repeatable pain intensity measurement method that requires minimal tools, provides rapid measurement of pain intensity under clinical and laboratory conditions. There are studies in which VAS is used to evaluate pain in prenatal patients. In VAS, the patient is asked to make a mark on a 10 cm horizontal line that shows his current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates that the patient's pain is very good (0 = no pain), and the other end indicates that the patient's pain is very bad (10 = the most severe). The length of the distance from the point where there is no pain (0) to the point marked by the patient shows the patient's pain intensity.

    one hour after intervention

  • State and Trait Anxiety Scales

    It is used to determine state and trait anxiety levels in individuals. State-Trait Anxiety Scale consists of a total of 40 items, 20 items each. The State Anxiety Scale requires the individual to describe how he or she feels at a particular moment and under certain circumstances. The total score of the scale varies between 20-80. A high score from the scale indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    one hour after intervention

  • cortisol level

    A high cortisol level indicates high stress, while a low level indicates low stress. Since cortisol levels follow a circadian rhythm, the timing of evaluation is crucial. Therefore, the first assessment in the study was conducted at 08:00, and the final evaluation was performed at 09:00.

    one hour after intervention

Study Arms (2)

endorphin massage group

EXPERIMENTAL

The researcher will show husbands how to give endorphin massage to their pregnant wives. Additionally, they will be asked to choose one of three different instrumental relaxation music pieces played without lyrics to help them relax, and the chosen music will be sent to the pregnant women via WhatsApp. They will be instructed to play the music while performing the endorphin massage. Husbands of pregnant women in the experimental group will be asked to apply a total of 20 minutes of endorphin massage within 1 hour, divided into two sessions of 10 minutes each.

Behavioral: Endorphin Massage

routine care group

NO INTERVENTION

They will receive routine nursing care.

Interventions

The person who will perform the endorphin massage opens his hands with his palms facing himself and draws a semicircle with the nails of his middle, ring and little fingers touching the sacrum. Then, a semicircle is drawn with the fingertips from each side of the spine, starting from the sacrum to the shoulder area, towards the waist area, As a result of this process, a palm shape is drawn on the back. Effleurage is applied from the shoulders to the arms up to the elbows. Effleurage is applied towards the shoulders by pressing from the elbows upwards with the back of the thumb. Effleurage is applied up to the sacrum by pressing circular movements with two thumbs on both sides of the spine. Effleurage is applied from the sacrum to the neck by pressing with two thumbs in a circular motion on both sides of the spine (approximately 1.5 cm apart). Lastly, effleurage is applied to the neck area and scalp, then petrissage (rubbing) is applied and the massage is completed.

endorphin massage group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being admitted to the hospital for cesarean section
  • Being willing to participate in the research

You may not qualify if:

  • Having psychiatric illness
  • native language not Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi

Manisa, 45060, Turkey (Türkiye)

RECRUITING

Study Officials

  • Yonca Çicek, PhD

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized study with experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 2, 2024

Study Start

October 9, 2023

Primary Completion

October 9, 2024

Study Completion

December 10, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations