NCT04709653

Brief Summary

Nurses can include the child in their occupational activities by using the therapeutic communication techniques they have learned during their education. However, there is no occupation-based nursing program that is routinely implemented for children in pediatric clinics. Therefore, the aim of this study is to investigate the effect of occupation-based nursing program on increasing child satisfaction as well as reducing the symptoms of chemotherapy in pediatric oncology patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

November 19, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

November 19, 2020

Last Update Submit

July 9, 2023

Conditions

Keywords

ChildCancerChemotherapyOccupationNursing

Outcome Measures

Primary Outcomes (3)

  • Change of chemotherapy-induced symptoms

    Measured by Memorial Symptom Assessment Scale (7-12) is used to evaluate the symptoms of chemotherapy. The scale is an 8-item scale used to evaluate the symptoms of pain, fatigue, sadness, nausea, itching, anxiety, change in taste, and insomnia experienced in the last two days by 7-12 year old children diagnosed with cancer. Symptoms are rated as 'present' or 'absent'. If symptoms are present, their duration is scored as "short duration (1 point)", "medium duration (2 points)" and "long duration (3 points)". The severity of the symptom is scored as "slight", "moderate", and "severe" in the same way as duration. The amount of distress caused by the symptom in the child is scored as "not at all (0 points)", "some (1 point), "moderate (2 points)" and "a lot (3 points)". It is 12. As the score obtained from the scale increases, it indicates that the negative effects of the symptom on the child increase.

    at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)

  • Change of psychosocial symptoms for hospitalized children

    Measured by Psychosocial Symptoms Diagnostic Scale for Hospitalized Children The scale developed to diagnose psychosocial symptoms for hospitalized children aged 6-12. Each statement in the 3-point Likert-type scale consisting of 24 items, which can be filled by the practitioner, was evaluated as "never", "sometimes" and "often" and scored as 0, 1 and 2, respectively. The highest score to be obtained from the scale is "48" and the lowest score is "0". A high score on the scale indicates that the child hospitalized in the clinic has psychosocial problems.

    at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)

  • Change in satisfaction for hospitalized children

    Measured by Child Satisfaction Form In the form prepared by the researchers in line with the literature, there are 10 questions to evaluate the satisfaction of the pediatric oncology patient. The form is in a five-point Likert type with the answers "I totally agree", "I somewhat agree", "I am undecided", "I do not agree" and "I do not agree at all". The minimum score that can be obtained from the form is 10 and the maximum score is 50. An increase in the scale score indicates that the child's satisfaction increases.

    at the baseline, immediately upon the completion of the program (fifth day), seven days after the intervention, and before discharge (14 days after the intervention)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Occupation-based nursing program

Other: Occupation-based nursing program

Control Group

EXPERIMENTAL

Routine nursing care

Other: Control Group

Interventions

First Session (Rug Weaving Activity): The child and the caregiver will be informed about the purpose and process of the research. The researcher will show in detail how to use rug weaving materials. Rug weaving activity will be started with the child. At the end of the 30-minute practice, the second session with the child will be planned and the session will be ended. Second Session (Rug Weaving Event Continues). Third Session (Rug Weaving Activity Continues): Rug weaving activity will be completed and the session will be ended by planning the fourth session with the child. Fourth Session (Origami Activity): A figure will be made with origami with the child. The child will be given support to make another figure. The fifth session hour will be planned with the child and the session will be ended. Fifth Session (Shape Making Activity with Chenille): A shape will be created with the child with chenille.

Intervention Group

Routine nursing care

Control Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old,
  • Inpatient treatment in Pediatric Hematology-Oncology service,
  • Children who can read and write in Turkish will be included in the study.

You may not qualify if:

  • Those who have visual or upper extremity impairment,
  • Mentally disabled,
  • Children in terminal period will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şule Şenol

Antalya, Konyaaltı, 7090, Turkey (Türkiye)

Location

Related Publications (1)

  • Mohammadi A, Mehraban AH, Damavandi SA. Effect of Play-based Occupational Therapy on Symptoms of Hospitalized Children with Cancer: A Single-subject Study. Asia Pac J Oncol Nurs. 2017 Apr-Jun;4(2):168-172. doi: 10.4103/apjon.apjon_13_17.

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This was pretest-posttest design, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assisstant

Study Record Dates

First Submitted

November 19, 2020

First Posted

January 14, 2021

Study Start

June 30, 2021

Primary Completion

May 20, 2022

Study Completion

October 30, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations