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Completed

NCT Number: NCT04850586

Structured Education and Multidisciplinary Team

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    The STAI measures two types of anxiety, state anxiety and trait anxiety. State Anxiety Inventory (STAI-I) is a sensitive tool for evaluating sudden changes in emotional reactions. It requires the individual to describe how they feel at a particular moment and under certain conditions and to respond by considering their feelings about the situation they are in. The scale consists of 20 items and the responses range from 1 to 4. The total score of the scale range from 20 to 80. High scores from the scale indicate high levels of anxiety and low scores indicate low levels of anxiety.

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

    Time frame: 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.

    This index consists of 10 items (feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers (e.g. bed to chair and back), mobility on level surfaces (e.g. stairs), and questions the physical competence of the individual. Each item (unable, needs help, independent) is scored between 0-15 and 0-20 indicates total dependency; 21-61 indicates severe dependency, 62-90 indicates moderate dependency, 91-99 indicates slight dependency, and 100 indicates independence.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Impact of Structured Education Given by a Multidisciplinary Team on Pain, Anxiety, and Activities of Daily Living in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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