The Impact of Nursing Interventions Based on Uncertainty In Illness Theory on Care Givers Of Children With Cancer

NCT03431155 | Completed DMC

• 1 other identifier: 2017/44
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this Randomised Controlled study was to determine the effect of nursing interventions based on Mishel's Uncertainty in Illness Theory on uncertainty, hopelessness, coping and compliance for care givers' of children with cancer. Sample was 46 (experimental group:23; control group: 23) cara givers of children. Experimental group received nursing interventions (6 modules, 200 minutes nursing education) based on Mishel's Uncertainty in Illness Theory while control group received routine hospital care. Data were collected 3 times: pre test, post test (2 weeks after intervention for experimental group or two weeks after from pretest for control group), and follow up (2 weeks after post tests).

Conditions

Pediatric Cancer; Nurse's Role

Keywords

children; cancer; care giver; uncertainty; nursing intervention; education

Outcome Measures

Primary Outcomes (1)

• Less uncertainty

  Means of Parents Perceived Uncertainty in Illness Scale: Parent/child From for participants in experimental group will be less.

  At the end of 4 week.

Secondary Outcomes (2)

• Less hopelessness

  At the end of 4 week.

• More coping and adaptation

  At the end of 4 week.

Study Arms (2)

Experimental group

EXPERIMENTAL

Nursing intervention

Other: Nursing intervention

Control Group

NO INTERVENTION

\- Receive routine nursing care

Interventions

Nursing intervention OTHER

Nursing Intervention: Protocol and education booklet were developed according to literature and Theory. There were six modules (10 session) which aimed to personal education for every care givers. Every session took 20 minutes and total 200 minutes. First 5 modules finished within 3 days and aafter one week last module completed (to summarize process). Also individual counseling were made.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Care giver of children with cancer who is next to children during the hospital process.
• Children diagnosed and continued to clinical therapy in one of two university hospitals.
• At least have the primary education (5 year education)
• Child get at least one cure chemotherapy/radiotherapy
• Care givers' age must be et least 18 year-old
• Care giver can speak and understand Turkish fluently

You may not qualify if:

• Care giver with psychiatric disorder
• Child has loss of function due to cancer related operation (amputation, etc)
• Having a child whose treatment of cancer finished
• Having a child whose disease is in remission
• Having a child whose disease relapse
• Having a child who is terminal term
• Having a child who is older than 18 year-old
• Prior to cancer diagnosis, children have a dhronic disease or genetic disorder

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Data were collected by a nurse (not researher) who did not know anything about participants of experiment and control group. * Data recorded on the computer by another nurse (without specifying the experiment and control group) * The experimental and control groups codified by the co-investigator. * The analysis of the data encoded by the groups was done by a statistical expert. Data collectors, statistical analyzes and report writing were blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Nursing

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 13, 2018
• Study Start: January 15, 2019
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)