Pain Clinical Trial
Official title:
Endorphins Applied to Women Who Have Delivered Vaginally Effect of Massage on Pain
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 |
Verified date | May 2024 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Kayseri City Hospital | Kocasinan | Kayseri |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
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
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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