NCT04610151

Brief Summary

This study was conducted to determine the effects of guided imagery on postoperative pain management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 26, 2020

Last Update Submit

October 29, 2020

Conditions

Keywords

PatientPostoperativePainVisual Analogue ScaleGuided Imagery

Outcome Measures

Primary Outcomes (1)

  • A mean total score on the Visual Analogue Scale (VAS)

    A mean total score on the VAS of four and above indicates postoperative pain.

    first week

Study Arms (2)

Guided Imagery

EXPERIMENTAL

Guided Imagery Intervention:The pretest data of the patients with a pain score of 4 or higher according to VAS were collected. Afterwards, the experiment group patients were applied guided imagery.

Other: guided imagery

No-Reflexology Application , control group.

NO INTERVENTION

No intervention was applied on the control group patients.

Interventions

Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (

Guided Imagery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients at and over the age of 18
  • Patients who were able to speak Turkish
  • Patients who received spinal anesthesia

You may not qualify if:

  • Patients who had not previously used guided imagery
  • Patients any disease that could cause pain outside the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leyla ZENGİN AYDIN

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

April 1, 2018

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations