Structured Education and Multidisciplinary Team

NCT04850586 | Completed

• 1 other identifier: 45793301-604.01.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It is well-known that pre-operative education has a positive effect on patient recovery. This study was conducted to evaluate the impact of structured education given by a multidisciplinary team (surgeon, anesthesiologist, and nurse) on pain, anxiety, and activities of daily living in patients undergoing laparoscopic cholecystectomy.

Conditions

Pain; Anxiety; Activities of Daily Living

Keywords

anxiety; cholecystectomy; education; multidisciplinary team; pain

Outcome Measures

Primary Outcomes (1)

• The difference in pain scores measured by Visual Analog Scale between the two groups

  This scale is a unidimensional, valid and reliable scale in the measurement of acute pain intensity. This scale, which is comprised horizontally or vertically, consists of a 10 cm scale, at one end there is "no pain", at the other end there is "worst imaginable pain," with which the patient scores their pain. As the score on the scale increases, the severity of pain intensity increases.

  The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.

Secondary Outcomes (2)

• The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups

  Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).

• The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups

  The independence levels of the patients in both groups were evaluated using the Barthel Daily Living Activities Index on the 10th-day follow-up appointment.

Study Arms (2)

Education Group

EXPERIMENTAL

The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.

Other: Education Group

Control Group

NO INTERVENTION

Routine education was given to the patients in the control group. Routine education was administered by a nurse working in the clinic after the patients were admitted to the hospital. The patients in this group were not trained by a multidisciplinary team. In the routine training, patients were only informed about preoperative preparation.

Interventions

Education Group OTHER

The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.

Education Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing an elective laparoscopic cholecystectomy
• no loss of sensation related to vision and hearing
• opening to communication and cooperation
• no cancer diagnosis
• no chronic pain-related treatment
• no psychological disease diagnosis
• agreeing to participate in the study

You may not qualify if:

• undergoing emergency surgery
• hospitalized in the intensive care unit
• average score below 62 by Barthel Index

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

• Zelenikova R, Homzova P, Homza M, Buzgova R. Validity and Reliability of the Czech Version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). J Perianesth Nurs. 2017 Oct;32(5):429-437. doi: 10.1016/j.jopan.2016.03.007. Epub 2016 Dec 28.

  PMID: 28938978 BACKGROUND

• Zemla AJ, Nowicka-Sauer K, Jarmoszewicz K, Wera K, Batkiewicz S, Pietrzykowska M. Measures of preoperative anxiety. Anaesthesiol Intensive Ther. 2019;51(1):64-69. doi: 10.5603/AIT.2019.0013.

  PMID: 31280554 BACKGROUND

• Lee CH, Liu JT, Lin SC, Hsu TY, Lin CY, Lin LY. Effects of Educational Intervention on State Anxiety and Pain in People Undergoing Spinal Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Apr;19(2):163-171. doi: 10.1016/j.pmn.2017.08.004. Epub 2017 Nov 15.

  PMID: 29153299 BACKGROUND

• Allvin R, Ehnfors M, Rawal N, Idvall E. Experiences of the postoperative recovery process: an interview study. Open Nurs J. 2008;2:1-7. doi: 10.2174/1874434600802010001. Epub 2008 Jan 4.

  PMID: 19319214 BACKGROUND

• Pedziwiatr M, Mavrikis J, Witowski J, Adamos A, Major P, Nowakowski M, Budzynski A. Current status of enhanced recovery after surgery (ERAS) protocol in gastrointestinal surgery. Med Oncol. 2018 May 9;35(6):95. doi: 10.1007/s12032-018-1153-0.

  PMID: 29744679 BACKGROUND

• Craig-Schapiro R, DiBrito SR, Overton HN, Taylor JP, Fransman RB, Haut ER, Sacks BC. Meet your surgical team: The impact of a resident-led quality improvement project on patient satisfaction. Am J Surg. 2018 Oct;216(4):793-799. doi: 10.1016/j.amjsurg.2018.07.056. Epub 2018 Aug 27.

  PMID: 30177240 BACKGROUND

• Meissner W, Coluzzi F, Fletcher D, Huygen F, Morlion B, Neugebauer E, Montes A, Pergolizzi J. Improving the management of post-operative acute pain: priorities for change. Curr Med Res Opin. 2015 Nov;31(11):2131-43. doi: 10.1185/03007995.2015.1092122. Epub 2015 Sep 30.

  PMID: 26359332 BACKGROUND

• Zieren J, Menenakos C, Mueller JM. Does an informative video before inguinal hernia surgical repair influence postoperative quality of life? Results of a prospective randomized study. Qual Life Res. 2007 Jun;16(5):725-9. doi: 10.1007/s11136-007-9171-y. Epub 2007 Feb 8.

  PMID: 17286194 BACKGROUND

• Wongkietkachorn A, Wongkietkachorn N, Rhunsiri P. Preoperative Needs-Based Education to Reduce Anxiety, Increase Satisfaction, and Decrease Time Spent in Day Surgery: A Randomized Controlled Trial. World J Surg. 2018 Mar;42(3):666-674. doi: 10.1007/s00268-017-4207-0.

  PMID: 28875242 BACKGROUND

• Diez-Alvarez E, Arrospide A, Mar J, Alvarez U, Belaustegi A, Lizaur B, Larranaga A, Arana JM. [Effectiveness of pre-operative education in reducing anxiety in surgical patients]. Enferm Clin. 2012 Jan-Feb;22(1):18-26. doi: 10.1016/j.enfcli.2011.09.005. Epub 2011 Dec 7. Spanish.

  PMID: 22154548 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Elif Gezginci

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 20, 2021
• Study Start: March 1, 2019
• Primary Completion: August 29, 2019
• Study Completion: November 30, 2019
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)