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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05764512
Other study ID # 2023/09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date May 1, 2024

Study information

Verified date May 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 80
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
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)

Study Design


Related Conditions & MeSH terms


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 Kayseri City Hospital Kocasinan 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
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