NCT05915624

Brief Summary

The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery. The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery. Preoperative tele-nursing counseling has an effect on anxiety in same day surgery. Preoperative tele-nursing counseling has no effect on patient satisfaction in same day surgery. Preoperative tele-nursing counseling has an effect on patient satisfaction in same day surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 10, 2023

Last Update Submit

June 22, 2023

Conditions

Keywords

ambulatory surgeryanxietypatient satisfaction

Outcome Measures

Primary Outcomes (2)

  • Surgery-Specific Anxiety Scale

    It is a 5-point Likert-type scale. (1-Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Completely agree). The maximum score to be taken from the scale is 50. In the scale scoring system, the emotions experienced by the patients were collected in 3 different dimensions.

    two hours before going to surgery

  • Patient's Perception of Nursing Care Scale

    It was used to measure the satisfaction level of patients with nursing care. It is required to mark one of the 15 statements that make up the scale: Agree-5, Agree a little-4, Undecided-3, Disagree-2, Strongly Disagree-1 and No response-0. The score given for each item is taken as a basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude.

    two hours before discharge

Study Arms (2)

telephone counseling group

EXPERIMENTAL

After signing the voluntary informed consent form, the patients in the experimental group were given a Preoperative Patient Information Brochure, prepared by the researcher when they came to the hospital for the surgery date. Data will be collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery.

Other: telephone counseiling

Control group

NO INTERVENTION

The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form.

Interventions

One day before the operation, information was given about the operation process via tele-nursing and counseling was provided.

telephone counseling group

Eligibility Criteria

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

You may qualify if:

  • Above 18 years old,
  • Agreeing to participate in the research,
  • Persons who will undergo day surgery in the field of general surgery, urology, orthopedic surgery, plastic surgery, neurosurgery,
  • GKS score of 15,
  • Not addicted to alcohol
  • No psychiatric problems,
  • Not using antipsychotic, antidepressant and anxiolytic drugs
  • According to the ASA (American Society of Anesthesiologists) classification, ASA 1-2-3 -classification
  • Speech and hearing impaired
  • It is planned to include patients who have an open phone in the study.

You may not qualify if:

  • Preoperative hospitalization
  • Patients undergoing emergency surgery
  • Patients who want to leave the study at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ezgi Seyhan Ak

Istanbul, Şişli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant does not know which group he/she is in
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The patients in the experimental group will be given a Preoperative Patient Information Brochure prepared by the researcher when they come to the hospital for the surgery date after the voluntary informed consent form is signed. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

June 10, 2023

First Posted

June 23, 2023

Study Start

September 1, 2022

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations