NCT05169749

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

November 29, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

Operating room nurseNursing visitLaparoscopic surgeryPatient education

Outcome Measures

Primary Outcomes (2)

  • Change in State Anxiety Level

    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

    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

Study Arms (2)

Control-Service Nurse Group

OTHER

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.

Procedure: Control-Service Nurse Group

Experimental-Nursing Visiting Group

EXPERIMENTAL

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.

Procedure: Nursing Visiting Group

Interventions

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.

Control-Service Nurse Group

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-Nursing Visiting Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Uslu

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

Related Publications (6)

  • Carter L, Evans T. Preoperative visiting: a role for theatre nurses. Br J Nurs. 1996 Feb 22-Mar 13;5(4):204, 206-7. doi: 10.12968/bjon.1996.5.4.204.

  • Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. doi: 10.1111/j.1365-2648.2003.02972.x.

  • Guo P, East L, Arthur A. A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial. Int J Nurs Stud. 2012 Feb;49(2):129-37. doi: 10.1016/j.ijnurstu.2011.08.008. Epub 2011 Sep 22.

  • Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. doi: 10.1080/21642850.2014.900450. Epub 2014 Apr 28.

  • Sadati L, Pazouki A, Mehdizadeh A, Shoar S, Tamannaie Z, Chaichian S. Effect of preoperative nursing visit on preoperative anxiety and postoperative complications in candidates for laparoscopic cholecystectomy: a randomized clinical trial. Scand J Caring Sci. 2013 Dec;27(4):994-8. doi: 10.1111/scs.12022. Epub 2013 Jan 28.

  • Aydal P, Uslu Y, Ulus B. The Effect of Preoperative Nursing Visit on Anxiety and Pain Level of Patients After Surgery. J Perianesth Nurs. 2023 Feb;38(1):96-101. doi: 10.1016/j.jopan.2022.05.086. Epub 2022 Aug 13.

Study Officials

  • Yasemin Uslu, Asisst Prof

    Acıbadem Mehmet Ali Aydınlar Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. Prof.

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 27, 2021

Study Start

March 1, 2019

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations