The Effect of Occupation-Based Nursing Program Applied to Pediatric Oncology Patients

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04709653
Collaborator
(none)
60
1
2
11.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Occupation-based nursing program
  • Other: Control Group
N/A

Detailed Description

Stressful processes that pediatric oncology patients may be exposed to in the hospital can have a negative effect on the child's anxiety, decrease in activities, and consequently recovery and participation in hospital care. These processes are very difficult for school children as well as for all children. Hospitalization becomes a limiting factor for the school-age child in this period when he is open to mental and physical development, and he starts to attach more importance to socialization and independence. In addition, problems such as painful diagnosis and treatment procedures, side effects of chemotherapy drugs, and insufficient activity support in the hospital may cause the child to stay away from activities. For these reasons, pediatric oncology patients spend their time in their rooms during chemotherapy treatments. With non-pharmacological approaches that can be applied to pediatric oncology patients, chemotherapy-induced symptoms such as fatigue, pain, anxiety and nausea can be reduced, as well as helping to spend the time in the hospital more enjoyable and active. In the studies conducted, it is stated that these approaches are mostly distracting methods. In this context, the use of distraction methods in nursing care is a valuable aspect of care. In our country, randomized controlled studies in which nurses use non-pharmacological methods are quite limited. With the increase of these studies, the use of effective non-pharmacological methods for pediatric oncology patients will be widespread. This study was planned to examine the effect of occupation-based nursing program (OBaNup) in pediatric oncology patients in reducing the symptoms of chemotherapy and on child satisfaction. In the experimental part of the study; It is planned to conduct a randomized controlled single blind experimental study with 60 pediatric oncology patients, including 30 interventions and 30 controls, who received chemotherapy treatment. It is planned to apply OBaNup to the initiative group for an average of 30 minutes a day for five days. Since there is no routine occupation-based nursing program applied to children in the clinic, it is thought that this study can contribute to both the literature and nursing practices. Therefore, in the planned study; It is predicted that OBaNup applied to pediatric oncology patients can reduce the symptoms of chemotherapy and increase satisfaction.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This was pretest-posttest design, randomized controlled trial.This was pretest-posttest design, randomized controlled trial.
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Occupation-Based Nursing Program Applied to Pediatric Oncology Patients on Chemotherapy-Related Symptoms and Satisfaction
Actual Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Aug 20, 2022
Anticipated Study Completion Date :
Aug 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Occupation-based nursing program

Other: Occupation-based nursing program
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.

Experimental: Control Group

Routine nursing care

Other: Control Group
Routine nursing care

Outcome Measures

Primary Outcome Measures

  1. Change of chemotherapy-induced symptoms [5th day after the end of the application, 1 week after the application, 10-14 days after the application before discharge]

    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.

  2. Change of psychosocial symptoms for hospitalized children [5th day after the end of the application, 1 week after the application, 10-14 days after the application before discharge]

    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.

  3. Change in satisfaction for hospitalized children [5th day after the end of the application, 1 week after the application, 10-14 days after the application before discharge]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 7-12 years old,

  • Inpatient treatment in Pediatric Hematology-Oncology service,

  • Children who can read and write in Turkish will be included in the study.

Exclusion Criteria:
  • Those who have visual or upper extremity impairment,

  • Mentally disabled,

  • Children in terminal period will not be included in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Şule Şenol Antalya Konyaaltı Turkey 7090

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sule ŞENOL, Research assisstant, Akdeniz University
ClinicalTrials.gov Identifier:
NCT04709653
Other Study ID Numbers:
  • Akdeniz Unv
First Posted:
Jan 14, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sule ŞENOL, Research assisstant, Akdeniz University

Study Results

No Results Posted as of Aug 3, 2022