The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery

December 23, 2021 updated by: Yasemin Uslu, Acibadem University
A nursing visit is a method used for psychological preparation and information of patients. During nursing visits, the operating room nurse visits the patient before the surgery, informs the patient about the surgical process and nursing care practices and gives education. The study was conducted to determine the effect of nursing visit before laparoscopic surgery on the anxiety and pain level of the patient in the postoperative period.

Study Overview

Detailed Description

In this study, a structured education program was created, the visiting nurse was ensured to be the nurse who is involved in the patient's surgery, and the levels of anxiety and pain were evaluated according to objective criteria in the postoperative period on the patient group planned for laparoscopic surgery.

The study was conducted with 135 patients, 72 in the experimental group and 63 in the control group. The website https://www.randomlists.com/random-letters was used during the randomization of the patients. The patients were randomly assigned to the experimental and control groups according to their sequence numbers.

For the standardization of patient education, an education booklet was prepared in line with the literature, and the final version was prepared by consulting experts. The experimental group was educated by visits of the operating room nurse. The control group was educated by the service nurse. Data were collected with state-trait anxiety inventory and visual analog scale.

Visual analog scale (VAS)- The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points Spielberger State-Trait Anxiety Inventory - Anxiety inventory was developed by Spielberg et al. in 1970 and adapted into Turkish by Oner and Le Compte in 1977. This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level The State-Trait Anxiety Inventory was applied before the patient education and the State Anxiety Inventory after the education. The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively, and the State Anxiety Inventory was applied again 24 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ataşehir
      • İstanbul, Ataşehir, Turkey, 34752
        • Yasemin Uslu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who were 18 years old and above
  • who could speak Turkish and who were able to communicate
  • underwent laparoscopic general surgery (such as laparoscopic cholecystectomy, colon, inguinal hernia, appendectomy, incisional hernia, sleeve gastrectomy) were included in the study.

Exclusion Criteria:

  • Emergency and unplanned cases,
  • patients transferred to the intensive care unit after surgery,
  • patients with neurological or psychological problems were excluded from the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control-Service Nurse Group
Patient education lasting 20-30 minutes was provided by the nurse who gives care in the surgical inpatient floor before the surgery. The nurse provided the patient's admission to the postoperative surgical inpatient floor and follow-up.

Processing Steps

  • The State-Trait Anxiety Inventory was applied before the patient education
  • The State Anxiety Inventory was applied after the education.
  • The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively
  • The State Anxiety Inventory was applied again 24 hours after surgery.
Experimental: Experimental-Nursing Visiting Group
The nursing visit was done by the operating room nurse who will be involved in the patient's surgery, and the patient education lasted 20-30 minutes. The nurse, who carried out the nursing visit, welcomed the patient in the operating room, was next to the patient before anesthesia, and followed the patient to the recovery room after surgery.

Processing Steps

  • The State-Trait Anxiety Inventory was applied before the patient education
  • The State Anxiety Inventory was applied after the education.
  • The pain was monitored in accordance with the surgical patient follow-up protocol for 24 hours postoperatively
  • The State Anxiety Inventory was applied again 24 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Anxiety Level
Time Frame: Baseline to 24 hours postoperative
State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level. Before, the patient education (before surgery) After, the education (before surgery) 24 hours after surgery.
Baseline to 24 hours postoperative
Change in Pain Score
Time Frame: Baseline to 24 hours postoperative
Pain score is evaluated by Visual analog scale (VAS). The scale, which is used to evaluate the pain intensity, aims to explain the patient's pain in numbers. The scale requires the patient to score the pain as the absence of pain starting from 0 (zero) and unbearable pain to be evaluated over 10 (ten) points. Immediately after surger: Every 1 hour and 15 minutes after being admitted to the surgical inpatient floor (15 minutes-30 minutes-45 minutes-60 minutes), every next 2 hours and 30 minutes (90 mins-120 mins-150 mins-180 mins), every next 4 hours (4th-5th-6th-7th hour), every next 4 hours (11th-15th-19th-24th hours). Data were collected between the zero and 24 hours.
Baseline to 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yasemin Uslu, Asisst Prof, Acıbadem Mehmet Ali Aydınlar Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ATADEK 2018-16/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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