NCT05950425

Brief Summary

Parents whose children are in intensive care have to cope with many stressors in terms of psychological, physical, economic and social aspects. Especially during the discharge process, many reasons such as the fact that their children have a chronic disease, need for care, parents do not know how to provide the care their children need, the lack of professional health care teams provided by home care in our country, and therefore the care of the children is covered by the families, increase the anxiety levels of the parents. It increases the frequency of hospitalization of children or prolongs the length of stay in the intensive care unit, as appropriate care cannot be provided. In addition, frequent hospitalizations can cause damage to family dynamics. It has been determined that as the child grows, the difficulties experienced in the care of the child, the financial difficulties increase, the worries about the future and the constant relationship with the experts increase the stress of the parents and the stress is in parallel with the level of hopelessness. This is the factor that reinforces the anxiety and hopelessness in the daily life of parents. The fact that mothers whose children are in intensive care do not know the materials used, the procedures performed, the steps of the procedure, and what situations they will encounter at home may increase their stress-anxiety and hopelessness levels. Today, with the rapid development of technology, the use of educational technologies on the basis of learning and teaching has become widespread in health care education in the field of health, as in every field. It is important to address more than one sense organ in order for the education in the field of health to be more effective. Therefore, it is important to reduce the anxiety and hopelessness levels of the parents, to increase the self-confidence of the parents, to see general (physiological and psychological) improvements in children, and to reduce health costs with the training given to mothers with different education methods. The aim of this study is to determine the effect of aspiration training given by different methods on the level of anxiety and hopelessness of mothers whose children are in intensive care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 10, 2023

Last Update Submit

July 21, 2023

Conditions

Keywords

Educational MethodsChildMotherAnxietyHopelessness

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form:

    The questionnaire prepared by the researcher considering the literature consists of 22 questions. This form consists of three parts: 10 questions about the child, 7 questions about the parent and family characteristics, and 5 questions about the mother's anxiety.

    1st day

Secondary Outcomes (1)

  • The Beck Hopelessness Scale:

    1st and 8th day

Other Outcomes (1)

  • State Anxiety Inventory

    1st and 8th day

Study Arms (3)

Experimental I group (video training + standard training)

EXPERIMENTAL

This group will be trained with the aspiration training video shot by the researcher on the model. The video content will include the introduction of the materials used in the aspiration application, how to maintain sterility, the position to be given to the child during aspiration, and the sterile aspiration on the model. After obtaining the consent of the mothers in Experiment I group who participated in the study and were assigned by randomization method, they will be taken to the day room of the service and the training video will be watched on the computer. After the end of the video, if they have any questions, they will be answered and they will be taken to their child's intensive care room after wearing the equipment (bonnet, shoe covers, apron, mask) necessary for the standard education and providing hand hygiene.

Other: Aspiration training

Experimental II group (education booklet training + standard training)

EXPERIMENTAL

Aspiration training will be given to this group with a picture training booklet. The training booklet includes the purpose of aspiration, the materials to be used, the position to be given to the child during aspiration, the preservation of sterility, and the application of aspiration. Expert opinion will be taken for the training booklet to be used. After obtaining the consent of the mothers in the Experimental II group, who participated in the study and were assigned with the randomization method, they will be taken to the day room of the service and aspiration training will be given with a picture training booklet. After the training, the questions of the mothers will be answered. At the end of the illustrated training booklet training, mothers will be put in the necessary equipment (bone cap, shoe covers, apron, mask) for standard practice training and hand hygiene will be provided and they will be taken to the intensive care environment to their children's rooms.

Other: Aspiration training

Control group

NO INTERVENTION

The routine standard training given to this group in aspiration training will be used. In this training, one-to-one telling and showing are available. After obtaining the consent of the mothers in the control group who participated in the study and were assigned by randomization method, the necessary equipment (bone cap, shoe covers, apron, mask) will be put on and hand hygiene will be provided and they will be taken to the intensive care unit. After the mother is taken to the room where the child is staying, the equipment and apparatus connected to her child (monitor, infusion pump, NG probe, foley catheter, endotracheal tube, tracheostomy, etc.) will be introduced, equipment used in the treatment process of her child (mechanical ventilator, oxygen valve, aspirator, ambu, aspiration). probe, etc.) will be introduced and physical contact with the child will be supported and ensured.

Interventions

Pre-test application; All mothers whose children are hospitalized in the PICU will be filled in the questionnaires after verbally expressing and signing the informed consent before being admitted to the intensive care unit and starting the education. In practice; The mother of the child who is planned to be discharged from the intensive care unit is given training a week before. Aspiration training will be given to the Experimental I group with the video method, and to the Experimental II group with the picture training booklet method. The materials of these trainings will be given to the mothers and they will be asked to look after them when they come to the next care. Final test application; scales will be filled in the mother on the day of the child's discharge.

Experimental I group (video training + standard training)Experimental II group (education booklet training + standard training)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly mothers will be included in the study as more mothers take care of children in need of special care in Turkish society.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having aspiration application in the treatment of the child
  • Parent's ability to read and speak Turkish
  • Parent's willingness to participate in the study
  • Parent over 18 years of age
  • The child has reached the discharge stage
  • The mother has not done aspiration before
  • Hospitalization of the child in the intensive care unit between the working dates

You may not qualify if:

  • Variation of the child's health status during education
  • Parent has a mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversity

Meram, Konya, 42250, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Ağdaş D. (2008) Opinions of mothers of children hospitalized in the pediatric service of Cumhuriyet University Hospital regarding patient admission procedures and their expectations from nurses (Master's Thesis). Cumhuriyet University Institute of Health Sciences, Sivas. Ak, B. (2018). Child and nursing approach with chronic and life-threatening/fatal disease. Z. Conk, Z. Başbakkal, H. Bal Yılmaz, B. Bolışık (Ed.) in Pediatric Nursing (pp. 901- 936). Ankara: Academician Bookstore. Akşit S. & Cimete G. (2001) The effect of nursing care applied to mothers on the anxiety level of mothers when the child is admitted to the intensive care unit. C. U. Journal of the School of Nursing. 5(2): 25-36. Asatekin Yazgu, H. (2022). The Effect of Perceived Social Support on Anxiety and Anxiety Levels of Mothers with Their Baby in the Neonatal Intensive Care Unit [Unpublished master's thesis]. Istanbul University. Ayar, G., Şahin, S. , Yazıcı, M. U. , Coşkun, R. , Yakut, H. İ. & Demirel, F. (2015). Evaluation of Home Care Services in Pediatric Patients. Turkish Journal of Pediatrics, 9 (1) , 12-17 Aykanat Girgin, B. & Balcı, S. (2015). Home Care Needs of Physically Handicapped Children and Their Families. Gumushane University Journal of Health Sciences, 4 (2), 305-317 Biket, A. P., & Tönük, S. (2012). Examining the history of pediatric intensive care units and the current situation in Turkey with examples. Sigma, 4, 64-76. Bolışık, B. Z., Akçay Didişen, N., & Yavuz, B. (2014). Investigation of Use of Wet Wipes in Care of Mothers with Inpatient Children in Children's Hospital. Journal of Ege University Faculty of Nursing, 30(1), 91-100. Caicedo, C. (2014). Families With Special Needs Children. Journal of the American Psychiatric Nurses Association, 20(6), 398-407. https://doi.org/10.1177/1078390314561326

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Semra KÖSE

    Necmettin Erbakan University

    STUDY DIRECTOR

Central Study Contacts

Semra KÖSE, PhD, Asisstant Proffessor

CONTACT

Gülistan Gülmez, Masterstuden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Proffessor

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

July 10, 2023

Primary Completion

May 1, 2024

Study Completion

June 30, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

The decision to share the study results will be made during the study period or when it is concluded

Locations