NCT05521581

Brief Summary

H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women. H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women. H1-3 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the time of gas production in women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 20, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 20, 2022

Last Update Submit

August 26, 2022

Conditions

Keywords

hand massagecesarean deliveryachecomfortgas outletmidwife

Outcome Measures

Primary Outcomes (6)

  • inclusion of women in the study and filling out the introductory information form

    Women are included in the study by filling out the introductory information form. The information obtained will be recorded in the SPSS 20.0 package program.

    maximum one hour

  • ensuring the randomization of the women included in the study into the intervention and control groups

    Distributions are made to women included in the study and to control and intervention groups.

    Five min

  • practicing and observing hand massage

    Mothers assigned to the intervention group receive 2 sessions of hand massage. The first session is applied at the 6th hour after the cesarean section, and the second session is applied at the 12th hour after the cesarean section. Routine care is applied to the control group and hand massage is not applied.

    an average of 12-13 hours

  • assessment of pain

    Women in the intervention and control groups are assessed for pain with the Visual Analog Scale (VAS).

    five min

  • comfort assessment

    Women in the intervention and control groups will be evaluated with the Postpartum Comfort Scale.

    ten min

  • Evaluation of gas exit time

    The effectiveness of hand massage will be evaluated by looking at the time between cesarean section hours and gas release times of women in the intervention and control groups.

    five min

Study Arms (2)

intervention

EXPERIMENTAL

Hand massage will be applied to primiparous mothers who gave birth by cesarean section

Other: Hand massage

control

NO INTERVENTION

Routine care will be given to mothers who have given cesarean section and hand massage will not be applied.

Interventions

Hand massage will be applied to primiparous mothers who gave birth by cesarean section and its effect on pain, comfort and gas release times will be evaluated.

intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimiparous women who had a cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having primiparous pregnancy,
  • years old and over,
  • Able to speak Turkish and express himself in Turkish,
  • Does not have any disability (such as vision, hearing)
  • Having completed the 6th hour after cesarean delivery, hospitalized in the gynecology service,
  • Having undergone cesarean section with spinal anesthesia,
  • Having no findings such as wounds, nerve problems, history of surgery or amputation on their hands,
  • Single pregnancy,
  • Women who are open to communication and who are mentally and physically healty

You may not qualify if:

  • Not accepting to work,
  • Having a gas outlet before starting the application,
  • Presence of findings such as wounds on hands, nerve problems, history of surgery or amputation,
  • Having postpartum hemorrhage,
  • With uterine subinvolution,
  • Having a cesarean section with another type of anesthesia other than spinal anesthesia (such as general, epidural combined)
  • Having twin babies,
  • Having a premature baby (the baby needs more attention and care)
  • Women whose babies are hospitalized in the neonatal intensive care unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinem Dügeroğlu

Kırıkkale, 71100, Turkey (Türkiye)

Location

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
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment Women who had cesarean section in the institution were evaluated in terms of sample. They were divided into two groups as criteria and random sampling. be an order obtained a random number table, capable of random sampling automatically by means of programs on websites by specifying a number. samples. Selection of intervention and control groups determined by tossing a coin. The sample number was determined as 83 women who had a total of 166 cesarean section in each of the intervention and control groups. Considering the data losses, 10% more was calculated and it was planned to conduct the research with a total of 182 women (91 women in the intervention group, 91 women in the control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 30, 2022

Study Start

August 25, 2022

Primary Completion

January 25, 2023

Study Completion

March 25, 2023

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations