NCT05268328

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 7, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

January 31, 2022

Last Update Submit

March 2, 2022

Conditions

Keywords

Cesarean sectionFoot reflexologyPostpartum painPostpartum ComfortnursingBowel problems

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who have had cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women who have had cesarean section

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.1080/14767058.2018.1526913. 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.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nülüfer Erbil, Prof. Dr.

    Ordu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nülüfer Erbil, Prof.Dr

CONTACT

Mevlüde Alpaslan Arar

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 7, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2022

Study Completion

October 1, 2022

Last Updated

March 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share