Does Endorphin Massage Reduce the Anxiety of Pregnant Women?

Pregnancy Related Clinical Trial

Official title:

Does Endorphin Massage Applied Before Cesarean Section Reduce the Anxiety of Pregnant Women?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342154
• Other study ID #: MCBU-SBF-YC-03
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 10, 2024

Study information

• Verified date: March 2024
• Source: Celal Bayar University
• Contact: Yonca Çiçek, PhD
• Phone: +90507 698 09 54
• Email: yonca09[@]windowslive.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The sample size of the research was calculated using G*Power 3.1.9.4 software as a minimum of 34 with 95% power, 0.01 alpha, and 0.9 effect size. The sample size was planned as experimental (n=34) and control (n=34) groups. To ensure the equality of the samples in both groups, a simple randomization method was used, where pregnant women with odd hospital protocol numbers will be included in the experimental group and those with even numbers will be included in the control group. Pregnant women who are admitted for pre-cesarean section care will be informed about the study, and their voluntary consent will be obtained both in written and verbal form. Pre-tests will be administered to both the experimental and control groups at 08:00, and blood samples will be taken to measure cortisol levels. Subsequently, an intervention will be applied to those in the experimental group, while those in the control group will receive routine nursing care. At 09:00, post-tests will be administered to both the experimental and control groups, and blood samples will be taken again to measure cortisol levels. The pre-test and post-test results, as well as the mean cortisol levels, will be compared between the experimental and control groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 10, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Having psychiatric illness
• native language not Turkish

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• Endorphin Massage
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.

Locations

Country	Name	City	State
Turkey	Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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