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Completed

NCT Number: NCT04330612

Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.

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Key information

Conditions

Family Members Anxiety Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures

Exclusion criteria

  • Age under 18
  • Non-English speaking patients or families
  • Patients with families that would not be waiting in the hospital during the perioperative period

Treatment and study plan

Perioperative Updates

Other

In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready.

Primary outcomes

  1. Likert Score (0-5) of level of overall satisfaction

    Time frame: Overall satisfaction levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.

    Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period

  2. Likert Score (0-5) of anxiety level

    Time frame: Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.

    Likert Score (0-5) of anxiety level of family members throughout the perioperative period

  3. Likert Score (0-5) of level of satisfaction with perioperative updates

    Time frame: Satisfaction with perioperative updates measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.

    Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period

Secondary outcomes

  1. Spearman correlation between length of procedure and Likert score of anxiety level

    Time frame: Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.

    Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period

  2. Spearman correlation between length of procedure and Likert score of overall satisfaction

    Time frame: Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.

    Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period

  3. Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates

    Time frame: Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.

    Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Registry information

Official study title

Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2020
Registry last updated
Apr 1, 2020

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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