Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Completed

CT.gov ID

NCT05915624

Collaborator

Assoc.Prof.Ezgi Seyhan Ak (Other)

160

Enrollment

Location

Arms

8.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ambulatory Surgical Procedures	Other: telephone counseiling	N/A

Detailed Description

Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples. The power of the study (α) was accepted as 0.05 (95% confidence level), Type 2 error probability (β) was accepted as 0.20 (80% power level) and the effect size of 0.46 in the relevant literature (Pehlivan, 2021) was taken into account, and the minimum required minimum in the groups was taken into account. It was found that taking the sample size as 74 would be sufficient. In the study, it was aimed to have a total of 148 participants, 74 for the control group and 74 for the experimental group. Considering the possible loss, the study was completed with a total of 160 patients, 80 of which were in the control group and 80 in the experimental group.

While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

The participant does not know which group he/she is in

Primary Purpose:

Other

Official Title:

The Effect of Pre-Surgery Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery

Actual Study Start Date :

Sep 1, 2022

Actual Primary Completion Date :

May 30, 2023

Actual Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: telephone counseling group 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 One day before the operation, information was given about the operation process via tele-nursing and counseling was provided.
No Intervention: Control group 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.

Arm

Intervention/Treatment

Experimental: telephone counseling group

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

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

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

Surgery-Specific Anxiety Scale [two hours before going to surgery]
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.
Patient's Perception of Nursing Care Scale [two hours before discharge]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ezgi Seyhan Ak	İstanbul	Şişli	Turkey

Sponsors and Collaborators

Istanbul University - Cerrahpasa (IUC)
Assoc.Prof.Ezgi Seyhan Ak

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nasır Mehmet Özbek, Master Student, Istanbul University - Cerrahpasa (IUC)

ClinicalTrials.gov Identifier:

NCT05915624

Other Study ID Numbers:

IUCESEYHANAK001

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nasır Mehmet Özbek, Master Student, Istanbul University - Cerrahpasa (IUC)

ambulatory surgery

anxiety

patient satisfaction

Study Results

No Results Posted as of Jun 23, 2023