- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268328
The Effect of Foot Reflexology After Cesarean Section
The Effect of Foot Reflexology After Cesarean Section on Pain, Intestinal Motility and Comfort
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nülüfer Erbil, Prof.Dr
- Phone Number: +90 5358306357
- Email: nerbil@odu.edu.tr
Study Contact Backup
- Name: Mevlüde Alpaslan Arar
- Phone Number: 05428368190
- Email: mevlude_alpaslan@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Comfort Scale
Time Frame: 3 hour
|
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
|
|
Visual Analog Scale
Time Frame: 3 hour
|
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
|
|
Bowel Movements Monitoring Form
Time Frame: 3 hour
|
the time when women's bowel movements begin to be heard, when gas is removed, and when bowel emptying occurs.
|
3 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nülüfer Erbil, Prof. Dr., T.C. ORDU ÜNİVERSİTESİ
Publications and helpful links
General Publications
- 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: 10.1080/14767058.2018.1526913. Epub 2018 Oct 29.
- 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 13.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- eylul1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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