Structured Education and Multidisciplinary Team

NCT ID: NCT04850586

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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In this randomized controlled study was conducted with 60 patients undergoing elective laparoscopic cholecystectomy in a training and research hospital in Turkey between March and August 2019. The participants were divided into two equal groups. Verbal structured education and written documents were given to the training group before surgery by a multidisciplinary team. The control group had the routine education. Data were collected using a Patient Information Form, the State Anxiety Inventory, a visual analog scale, and the Barthel Index for Activities of Daily Living.

Conditions

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Pain Anxiety Activities of Daily Living

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Education Group

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.

Group Type EXPERIMENTAL

Education Group

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education Group

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* undergoing emergency surgery
* hospitalized in the intensive care unit
* average score below 62 by Barthel Index
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Elif Gezginci

RN, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Gezginci

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Saglık Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28938978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31280554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29153299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19319214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29744679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30177240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26359332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17286194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28875242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22154548 (View on PubMed)

Other Identifiers

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45793301-604.01.01

Identifier Type: -

Identifier Source: org_study_id

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