NCT06403566

Brief Summary

Postoperative incision pain is an acute pain that begins with the stimulation of neuroreceptors from surgical trauma and usually resolves within a few days. Today, the physiology of acute pain is better understood and new approaches to pain management are emerging. However, studies conducted in recent years have reported that postoperative pain management is inadequate, and therefore approximately 50-80% of patients still experience moderate to severe pain

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

May 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

May 3, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • hand massage

    hand massage reduces women's pain score 0-10 points

    will be checked on the 2nd postoperative day

  • back massage

    back massage women's pain score 76-100 points

    will be checked on the 2nd postoperative day

  • hand massage

    hand massage improves women's scores by reducing sleep problems

    will be checked on the 2nd postoperative day

  • back massage

    back massage improves women's scores by reducing sleep problems

    will be checked on the 2nd postoperative day

Study Arms (3)

hand massage application

EXPERIMENTAL

hand massage will be applied before and after surgery

Other: hand massage

back massage application

ACTIVE COMPARATOR

back massage will be applied before and after surgery

Other: hand massage

control group

NO INTERVENTION

no intervention will be made

Interventions

three group randomized controlled trials

Also known as: back massage
back massage applicationhand massage application

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen undergoing hysterectomy surgery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range 25-65,
  • Elective surgery,
  • Lying in the hospital for at least 2 days after surgery,
  • Operated under general anesthesia

You may not qualify if:

  • No serious complications developed after surgery,
  • Never had a back or hand massage before,
  • Cognitive, effective and without any problem preventing communication,
  • No psychiatric problems,
  • Patients receiving a single type of analgesic drug (non-narcotic analgesics) to ensure homogeneity of the groups and to increase the reliability of the study results,
  • Patients not using Patient Controlled Analgesia (PCA) will be included in the sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Karaçay Yıkar

Adana, Sarıcam, 00130, 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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 8, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations