Acupressure Applied After Cesarean Section on Postpartum Pain

January 7, 2024 updated by: Hilal Begüm Çayır, Eastern Mediterranean University

The Effect of Acupressure Applied After Cesarean Section on Postpartum Pain and Postpartum Comfort: A Randomized Controlled Study

Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hilal Begum Cayır, Research Assistant
  • Phone Number: 05338724986
  • Email: hilalbegm@gmail.com

Study Locations

  • Cyprus
      • Famagusta, Cyprus, 090
        • Hilal Begum Cayır

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

18-49 age women

Description

Inclusion Criteria:

  • agreeing to participate in the research,
  • be between the ages of 18-49,
  • To give birth by cesarean section between 37-40 weeks,
  • Having a healthy and live birth at the end of a single pregnancy,
  • Receiving spinal anesthesia
  • Being able to read and write Turkish and be open to communication.

Exclusion Criteria:

  • Absence of pain in the 2nd hour postpartum
  • Having a cesarean delivery after a risky pregnancy,
  • Having a chronic illness
  • Having severe systemic disease
  • Not receiving spinal anesthesia
  • Having a body mass index over 25,
  • Have previous acupressure experience.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
control group
acupressure group
Women who are in acupressure will apply the application after cesarean section 2nd hour after applying the data collection forms (descriptive features formula, VAS, WHO). For women on acupressure, the application will be applied manually to the SP6, P6 and L14 points in the order indicated by the drawing with the index or middle finger, 1-1.5 cm depth for 5 seconds, pressing for 5 seconds, resting for 2 seconds and continuing for 2 minutes to go. will be with you. VAS will be filled again after the application.
Behavioral: acupressure
The acupressure points to be used in the research are located on the inner side of the lower leg, 4 fingers above the ankle and on the spleen meridian behind the tibia (SP6), which was previously effective in reducing pain, and located three fingers above the wrist (in the middle of the 2nd metacarpal bone, on the dorsum of the hand, adjacent The points determined as P6 (located between the metacarpal bones) and LI4 located in the space between the thumb and index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied by a certified researcher to women in the acupressure group. will be done

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
visual analog scale
Time Frame: 5 minutes
VAS has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a generally accepted, safe and easily applicable measurement tool in the world literature, consists of a 10 cm long line and there are subjective descriptive statements at both ends of the scale (0 cm = no pain and 10 cm = unbearable pain). The individual marks the appropriate place for his/her pain on this 10 cm line on the scale. The distance from the beginning of the scale to the point where the individual marks is measured with a ruler, and the pain intensity of the individual is determined numerically in cm. A low score obtained from the VAS indicates that the individual's pain intensity is low/low, and a high score indicates high/severe. The VAS is sensitive to pharmacological and non-pharmacological modalities that alter the pain experience.
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postpartum comfort scale
Time Frame: 15 minutes
It was developed by Karakaplan and Yıldız (2010) to determine postpartum comfort. The scale is likert type and consists of 34 items. Each item is scored between "strongly agree" (5 points), and "strongly disagree" (1 point). 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 scale has three sub-dimensions as "physical, psychospiritual and sociocultural". An increase in the score obtained from the scale indicates an increase in comfort. The Cronbach Alpha reliability of the scale was found to be .78 for the total DSQ.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Mediterranean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETK00-2023-0107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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