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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05169749
Other study ID # ATADEK 2018-16/33
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date October 1, 2019

Study information

Verified date December 2021
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
Nursing Visiting 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.

Locations

Country Name City State
Turkey Yasemin Uslu Istanbul Atasehir

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Carter L, Evans T. Preoperative visiting: a role for theatre nurses. Br J Nurs. 1996 Feb 22-Mar 13;5(4):204, 206-7. Review. — View Citation

Coll AM, Ameen JR, Mead D. Postoperative pain assessment tools in day surgery: literature review. J Adv Nurs. 2004 Apr;46(2):124-33. Review. — View Citation

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 — View Citation

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. Epub 2014 Apr 28. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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