Endorphin Massage Application to Women Who Gave Birth Vaginally

Pain Clinical Trial

Official title:

Endorphins Applied to Women Who Have Delivered Vaginally Effect of Massage on Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764512
• Other study ID #: 2023/09
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: March 2023
• Source: TC Erciyes University
• Contact: Nurseli SOYLU
• Phone: 05446101787
• Email: nurselisoylu[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. In addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. It is also known as the happiness hormone. It is stated that back massage will increase the release of endorphin hormones by relaxing the mother. In other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort. Studies have shown that endorphin massage applied to pregnant women reduces back pain. In another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. In the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety. When the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. The fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. It is aimed to determine the effect on endorphin level.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

Inclusion Criteria:

• 37-40. 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Birth, First
• Pain

Intervention

Other:
• Endorphin massage
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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Health Sciences	Melikgazi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

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