NCT05316207

Brief Summary

Introduction: Failure to follow-up patients by healthcare professionals after discharge may increase the development of anxiety and complications in patients. Aim: The aim of this study is to determine the effects of tele-nursing method to patients who have undergone Open Heart Surgery (OHS) after discharge on anxiety and some other complications. Material and Methods:This quasi-experimental randomized controlled study, which was conducted in a private hospital between November 2020 and April 2021, included 75 patients, 38 from the Intervention (IG) and 37 from the Control Group (KG). IG and CG patients were provided routine treatment and care. In addition to the IG, training and counselling were provided at least four times by phone calls between the first week after discharge and the end of the first month. Descriptive Form and State-Trait Anxiety Inventory (STAI-S and T) were administered to all patients before discharge, and STAI-S was administered at the end of the first month after discharge. Post-discharge complications were evaluated by medical doctor in both groups. These data, number of hospitalization and readmission rates were obtained from hospital records.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 14, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

AnxietyComplicationReadmissionHospitalization

Outcome Measures

Primary Outcomes (1)

  • Determination of change in anxiety levels between groups before discharge and one month after discharge

    Anxiety levels of all participants who met the inclusion criteria were measured using the state and trait anxiety scale in the pre-test. At the end of the first week after discharge, the intervention was started for the patients in the study group and the intervention was completed at the end of the first month after discharge. One month after discharge, the state anxiety levels were measured again with the state anxiety scale.

    State and trait anxiety levels were measured 72 hours before discharge for all participants who met the inclusion criteria.State anxiety levels of all participants were measured one month after discharge.

Secondary Outcomes (1)

  • Rates of Complication Development

    Complications developed in both groups were recorded at the end of the first week and the end of the fourth week after discharge.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

IG was formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and whose routine controls were determined by the randomization method. The patients in the IG would call by the researcher at least four times, at the end of the first, second, third and fourth weeks after discharge, to provide education and counseling via tele-nursing. In these phone calls, the current problems of the patient, if any, and the issues that should be paid attention to during the home care process after open heart surgery were explained.It was stated that, unlike the patients in CG, patients in IG would be called by the researcher at least four times at the end of the first, second, third and fourth weeks after discharge to provide education and counseling via tele-nursing.

Other: Telenursing

Control Group

NO INTERVENTION

The patients in the CG were formed from 40 patients who received routine care, treatment and education services of the clinic after open heart surgery, and who were determined by the randomization method, whose routine controls were made after discharge. No application was made to the patients in the CG by the researcher within the scope of the study. However, the researcher gave the phone number to the patients in the CG in terms of their right to receive ethical and professional care, and it was stated that they could call between 10:00 and 22:00 if needed. The reasons for calling the investigator from the CG were recorded .

Interventions

From the end of the first week after discharge to the end of the first month, patients were counseled over the phone during the home process. Complications were followed up.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eighteen years and older,
  • Able to speak and understand Turkish,
  • Without hearing, comprehension, vision and speech problems,
  • Open heart surgery for the first time,
  • Those who were not diagnosed with depression or anxiety disorder before surgery and didn't use medication for this purpose,
  • Having a mobile phone that can take photos by herself/himself or her/his attendants,
  • No serious complications to delay hospital discharge,
  • Patients who volunteered to participate were included in the study.

You may not qualify if:

  • Patients who wished to withdraw from the study after volunteering were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Park Hospital

Gaziantep, Şahinbey, 27027, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Kadiriye Pehlivan, MSc RN

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR
  • Ayla Yava, Prof, RN

    Hasan Kalyoncu Üni̇versi̇tesi̇ University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Intervention group and control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Research Assistant

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 7, 2022

Study Start

November 1, 2020

Primary Completion

April 21, 2021

Study Completion

April 21, 2021

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations