NCT05799547

Brief Summary

A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. The cold application examined in our research, is among these applications. participants will be determined by the block randomization method. Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. Only the routine practice of the clinic will be applied to the control group. Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form. When the studies were examined, no other study was found in the same application as our study. Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.

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
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable pain

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

20 days

First QC Date

January 10, 2023

Last Update Submit

April 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual analog scale (VAS)

    The visual analog scale is used to assess pain. The person marks the pain he feels on a ten-centimeter chart that expresses the absence of pain on one side and the pain he feels at the peak on the other side.

    1 week

Study Arms (2)

control group

NO INTERVENTION

experimental group

EXPERIMENTAL
Other: cold group

Interventions

Application will be made in the form of 10 minutes of application to the cesarean section incision, 20 minutes of break and 10 minutes of application.

experimental group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postpartum women who had cesarean section surgery
  • Having had a previous cesarean section,

You may not qualify if:

  • Those who have problems in postpartum vital signs and bleeding control
  • Those who have systemic diseases that may affect cold application
  • Those who are distressed and not suitable for practice by the service midwives and doctors,
  • Those who do not want to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

April 5, 2023

Study Start

June 20, 2023

Primary Completion

July 10, 2023

Study Completion

August 20, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04