Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children

NCT06237894 | Unknown

• 1 other identifier: BSEU
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.

Conditions

Multisensory Stimulation; Child, Only; Postoperative Pain; Fear

Outcome Measures

Primary Outcomes (3)

• Descriptive Information Form

  The form prepared by the researchers in line with the literature consists of 19 questions including socio-demographic characteristics, information about the child's disease, and the parent's perception of pain and fear. This form will also record the child's physiological parameters (heart rate and oxygen saturation) during the painful procedure.

  one year

• Wong Baker Faces Pain Rating Scale

  This scale is rated from 0 to 10. 0 indicates no pain and 10 indicates the most severe pain. Pain is requested to be evaluated according to facial expression. The scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. This scale is used to diagnose pain in children between the ages of 3-18. Wong Baker Pain Rating Scale The guideline recommends that clinicians use a validated pain rating scale when assessing postoperative pain and adjust treatment accordingly (strong recommendation, low-quality evidence), but there is insufficient evidence on the effect of different pain rating scales on postoperative pain outcomes. Therefore, when choosing a specific pain assessment tool, factors such as developmental status, cognitive status, level of consciousness, level of education, cultural and language differences should also be taken into consideration.

  one year

• Children's Fear Scale

  Children's Fear Scale, the scale whose validity and reliability was established by Gerçeker et al. (2018), is used to measure the child's anxiety level. Children's Fear Scale is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no fear) to scared face (4 = severe fear). Pain and anxiety before and during the procedure can be used by families and researchers to evaluate children and is intended for children between the ages of 5-10. Children's Fear Scale was created based on McKinley et al.'s (2003) Faces Anxiety Scale, which was developed to measure the fear or anxiety of adults in the intensive care unit. It is a scale consisting of one item and five gender-neutral facets. Facial muscle changes in fearful expressions were drawn by a graphic artist based on photographs of scared faces.

  one year

Study Arms (1)

Multisensory Stimulation

EXPERIMENTAL

Other: Multisensory Stimulation

Interventions

Multisensory Stimulation OTHER

Multisensory Stimulation

Multisensory Stimulation

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children are between the ages of 5-10,
• Having undergone a surgical intervention,
• Does not have an additional disease/condition that will affect the child's oxygen saturation, blood pressure and heart rate,
• Two hours have passed since the last painful attempt,
• Children whose parents agree to participate in the study will be included in the study.

You may not qualify if:

• Hearing and vision impaired
• Does not have a mental disability
• Children who do not have a parental consent form will not be included in the research.

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 2, 2024
• Study Start: June 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share