Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy

NCT03753542 | Completed Results DMC

• 1 other identifier: Enr # 12/2015/912
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT Background: Today, a wide range of pediatric cancers is treated by chemotherapy. More than 21 side effects of chemotherapy have been identified. Among those nausea; vomiting, infection and anemia are most common. The adverse effects are normally managed by the parents at home. Ineffective coping and lack of knowledge about chemotherapy side effect management leads parents stress. Contemporary research evidence that Nurse-led education, booklet providence and follow up about chemotherapy and side effect management, help to decrease parents anxiety and depression. Objectives: To measure the effect of nurse-led multimedia education, booklet providence and telephonic follow up about chemotherapy and side effects management on parents anxiety and depression of children receiving chemotherapy for the first time. Methodology: A randomized control trial will be conducted in the department of chemotherapy at Indus Children Cancer Hospital Karachi from March 2018 to August 2018 on parents of children below 18 years of age undergoing chemotherapy for the first time. Total 100 parents will be randomly divided into Intervention group (n=50) and Control Group (n=50). The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management. The Control group will receive routine care. Parent's anxiety and depression will be identified by using DASS-21 and generalized estimating estimation will be used to analyzed the data. Keywords: Nurse-led, Multimedia education, Booklet, telephonic follow-up, chemotherapy, side effects, parents, anxiety, depression, children, cancer

Conditions

Chemotherapy Effect

Keywords

chemotherapy, side effects, parents, anxiety, depression

Outcome Measures

Primary Outcomes (1)

• Depression, Anxiety and Stress Scale - 21 (DASS-21)

  DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity

  up to 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management

Other: Multimedia education, booklet Providence and tele-nursing follow-up

Control

NO INTERVENTION

The Control group will receive routine care

Interventions

Multimedia education, booklet Providence and tele-nursing follow-up OTHER

Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents along with their children newly diagnosed with cancer in last three weeks
• Parents along with their children schedule to receive first time chemotherapy in the outpatient department

You may not qualify if:

• Parents along with their children refused to participate
• Parents along with their children already receiving interventions like multimedia education, booklet providence and telephonic follow up for chemotherapy and side effect management
• Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/ Antidepressant)
• Parents showing uneasiness and discomfort during educational session.

Sponsors & Collaborators

• Nomi Waqas Gul: lead
• Indus Hospital and Health Network: collaborator

Study Sites (1)

Indus Children Cancer Hospital Karachi

Karachi, Sindh, Pakistan

Location

Related Publications (25)

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  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

As the study was conducted in single setting, hence the result may not be generalized. Further studies are recommended to measure its general effect.

Results Point of Contact

• Title: Nomi Waqas Gul, Student MSN DUHS ION and Asst. Controller Sindh Nurses Examination Board, Karachi
• Organization: Institute of Nursing Dow University of Health Sciences, Karachi/Sindh Nurses Examination Board, Karachi

nomiwg@gmail.com

0345-2506790

Study Officials

• Dr. Mehwish HUSSAIN, PhD (Statistics)

  Assistant Professor, DUHS, Karachi

  STUDY CHAIR

• Dr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP

  Indus Hospital Karachi

  STUDY CHAIR

• Mr. Hakim Shah, MSN

  Associate Professor Institute of Nursing Dow University of Health Sciences Karachi

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 27, 2018
• Study Start: September 6, 2018
• Primary Completion: December 30, 2018
• Study Completion: June 15, 2019
• Last Updated: July 28, 2022
• Results First Posted: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)