Clinical trial NCT04850586: Structured Education and Multidisciplinary Team
Official title: The Impact of Structured Education Given by a Multidisciplinary Team on Pain, Anxiety, and Activities of Daily Living in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Activities of Daily Living
Keywords: anxiety
cholecystectomy
education
multidisciplinary team
pain
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference in pain scores measured by Visual Analog Scale between the two groups
timeFrame: The participants' pain levels were evaluated using the VAS at 06:00 AM on the first day of surgery.
Secondary outcomes:
measure: The difference in anxiety scores measured by State-Trait Anxiety Inventory between the two groups
timeFrame: Anxiety levels were evaluated using the STAI-I just before discharge (postoperative 1st day).
measure: The difference in independence levels measured by the Barthel Daily Living Activities Index between the two groups
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Elif Gezginci
role: PRINCIPAL_INVESTIGATOR
References:
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