Postoperative PainNCT05268328
The Effect of Foot Reflexology After Cesarean Section
An observational study of Postoperative Pain and Gastrointestinal Motility Disorder, run by Nülüfer Erbil.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Gastrointestinal Motility Disorder
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women who have had cesarean section
Who may be able to join
- 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,
Show all 13Show fewer
- 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,
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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):
Read more
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.
- Keywords
- Cesarean section, Foot reflexology, Postpartum pain, Postpartum Comfort, nursing, Bowel problems
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nülüfer Erbil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nülüfer Erbil, Ordu University
- Investigators
- Nülüfer Erbil, Prof. Dr., Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268328
- Sponsor's protocol ID
- eylul1
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30231787Dikmen 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.
PubMed 29776873
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology After Cesarean Section on Pain, Intestinal Motility and Comfort
- ClinicalTrials.gov ID
- NCT05268328
- Acronym / sponsor ID
- eylul1
- Keywords
- Cesarean section, Foot reflexology, Postpartum pain, Postpartum Comfort, nursing, Bowel problems
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nülüfer ErbilUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women who have had cesarean section
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Results publication: PubMed 30231787Altraigey 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.
- Results publication: PubMed 29776873Dikmen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nülüfer Erbil, Prof. Dr. principal investigator
Ordu University
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Gastrointestinal Motility Disorder, run by Nülüfer Erbil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nülüfer Erbil, Prof.Dr (+90 5358306357, nerbil@odu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Comfort Scale (time frame: 3 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.