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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05268328
Other study ID # eylul1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date October 1, 2022

Study information

Verified date March 2022
Source T.C. ORDU ÜNIVERSITESI
Contact Nülüfer Erbil, Prof.Dr
Phone +90 5358306357
Email nerbil@odu.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Standardized, quality and evidence-based nursing care after cesarean section is important to prevent or minimize complications that may occur after cesarean section. This evidence-based care will contribute to the shortening of the recovery period of the mother, the early start of postpartum bowel movements, the decrease in the perceived pain level, and the increase in postpartum comfort, thus facilitating the adaptation to new life and roles. On the other hand, although a limited number of studies reported the effects of reflexology, no study investigating the effect of reflexology on pain, comfort level and GIS motility developed after SD was found. In this study, it was aimed to determine the effect of foot reflexology on pain, intestinal motility and comfort after cesarean section. Hypothesis(s): H1: Foot reflexology after cesarean section reduces the level of pain perception. H2: Foot reflexology after cesarean section increases intestinal motility. H3: Foot reflexology after cesarean section increases postpartum comfort.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date October 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria - 18 and over, - Performing SD under general anesthesia, - Cesarean section at 37-42 weeks of gestation, - The only live SD made, - Written / verbal communication can be established, - At least primary school graduate, - Not having any problems during her pregnancy, - Women who agree to participate in the study will be taken into the sample. Exclusion Criteria - Being under 18 years old, - Those who gave birth by cesarean section before 37-42 weeks of gestation, - Having chronic constipation, diarrhea and using any laxative type medication, - Having problems such as fractures, dislocations, arthritis, phlebitis, wounds, burns, fungus, eczema, inflammation in the foot tissue, - Having cardiovascular system disease,

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nülüfer Erbil

References & Publications (2)

Altraigey A, Ellaithy M, Atia H, Abdelrehim W, Abbas AM, Asiri M. The effect of gum chewing on the return of bowel motility after planned cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 May;33(10):1670-1677. doi: 10.108 — View Citation

Dikmen HA, Terzioglu F. Effects of Reflexology and Progressive Muscle Relaxation on Pain, Fatigue, and Quality of Life during Chemotherapy in Gynecologic Cancer Patients. Pain Manag Nurs. 2019 Feb;20(1):47-53. doi: 10.1016/j.pmn.2018.03.001. Epub 2018 Dec — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum Comfort Scale t consists of 34 items. A 5-point Likert-type scale scoring system was used, which will enable an evaluation to be made for each item that determines the situation to be measured. For each item, expression and scoring ranging from "strongly agree" (5 points) to "strongly disagree" (1 point) were made. I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution. Basically, low comfort is expressed by 1 and high comfort by 5. Since the scale is gathered under three factors, it can evaluate postpartum comfort in 3 dimensions (physical, psychospiritual, sociocultural). 3 hour
Primary Visual Analog Scale Visual Analog Scale A ruler that is 10 cm or 100 mm long, with painlessness (0, zero) on one end and the highest possible pain (10, ten) on the other end, can be used horizontally or vertically. It is stated that vertical use of the scale is more appropriate because it gives quick results and is easy to apply. In this study, the vertical form of the scale will be used. Clina et al. (1992) evaluated the VAS results as 0 cm "no pain", 0.5-3 cm "mild pain", 3.5-6.5 cm "moderate pain", 7-10 cm "severe pain". A new VAS form will be used in each application so that the woman can see her previous pain score and not be affected by it. 3 hour
Primary Bowel Movements Monitoring Form the time when women's bowel movements begin to be heard, when gas is removed, and when bowel emptying occurs. 3 hour
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