Effect of Guided Imagery Method on Procedural Pain in Children

NCT04978532 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted as a randomized controlled experimental trial. The children who attended a pediatric surgical clinic for venipuncture divided into two groups via randomization in the computer environment. After the randomization, the children in the guided imagery group listened to a voice recording prepared in a studio during venipuncture. This voice recording named 'Stroll in the Forest' helped the children to imagine that they are strolling in a forest and guided them. On the other hand, no application was performed on the children in the control group during the venipuncture. The primary outcome of the study was pain and secondary outcomes were heart rate and oxygen saturation values. The pain was evaluated by the children, parents, and observer. The pulse and oxygen saturation values were measured before, during, and after the venipuncture.

Conditions

Procedural Pain; Pain, Acute

Keywords

guided imagery; pain management; procedural pain; venipuncture

Outcome Measures

Primary Outcomes (2)

• Change of pain from before venipuncture to after venipuncture (assessed by children)

  Pain assessed by children with Faces Pain Scale-Revised (FPS-R). This self-report scale is used to determine the level of acute pain. This scale is suitable for the use of children in the age range of 4-16 years and it is a commonly preferred valid and reliable scale. The scale is composed of a total of 6 facial expressions, rated from 0 to 10, starting from a neutral face expression (0 point) and including a picture of a face expressing the existence of severe pain without tears (10 points).

  Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)

• Change of pain from before venipuncture to after venipuncture (assessed by parents and the observer)

  Pain assessed by parents and the observer with Visual Analog Scale (VAS). VAS is composed of a 100-mm horizontal line and the point "0" of this line expresses "no pain" and the point "10" expresses "worst pain". Firstly, the individual marks the intensity of the pain he/she perceives and the point marked by him/her is measured by using a ruler so that the pain score is determined

  Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)

Secondary Outcomes (2)

• Heart Rate

  Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)

• Oxygen Saturation

  Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)

Study Arms (2)

Guided Imagery Group

EXPERIMENTAL

One minute before venipuncture and during venipuncture, the children in the guided imagery group listened to a voice recording prepared in a studio. This voice recording named 'Stroll in the Forest' helped the children to imagine that they are strolling in a forest and guided them.

Other: Guided Imagery

Control Group

OTHER

No intervention was performed to reduce pain in the control group.

Other: Control Group

Interventions

Guided Imagery OTHER

The children in the guided imagery group listened to a voice recording named 'Stroll in the Forest' before and during venipuncture. One minute before venipuncture, children wore an earphone and voice recording started. Children closed their eyes, imagined the text content, and focused on the voice recording while listening to the voice. It is a voice recording that helps the children in the guided imagery group to imagine that they are strolling in a forest and guides them.

Guided Imagery Group

Control Group OTHER

No intervention was made in the children.

Control Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Speaking Turkish as a native speaker by children and parents,
• Being between the ages of 8 and 12,
• Not taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
• Having body temperature at normal level (36.5-37.2⁰C),
• Having no disease that can cause chronic pain,
• Having no auditory, mental, and neurological disability that can affect their participation,
• Having no negative symptom-history during previous venipuncture,
• Having no allergy to strawberry included in the guided imagine text, and having no fear about forests and squirrels.

You may not qualify if:

• Not speaking Turkish as a native speaker by children and parents,
• Being younger than 8 years old and older than 12 years old,
• Taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
• Having body temperature at a higher than normal level,
• Having a disease that can cause chronic pain,
• Having auditory, mental, and neurological disability that can affect their participation,
• Having negative symptom-history during previous venipuncture,
• Having allergy to strawberry included in the guided imagine text, and having fear about forests and squirrels.

Sponsors & Collaborators

• Biruni University: lead
• Istanbul University: collaborator

Study Sites (1)

İstanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Acute Pain; Agnosia

Interventions

Imagery, Psychotherapy; Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zeynep Erkut, PhD

  Biruni University

  PRINCIPAL INVESTIGATOR

• Duygu Gözen, PhD

  Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 27, 2021
• Study Start: February 1, 2017
• Primary Completion: March 30, 2018
• Study Completion: October 21, 2018
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

TU (1)