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Clinical Trials/NCT04669379
NCT04669379
Terminated
Not Applicable

Preoperative Optimization of Patient's Expectations by the Use of an Online-Tool - a Randomized Controlled Trial

Philipps University Marburg Medical Center1 site in 1 country29 target enrollmentJune 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Undergoing Surgery
Sponsor
Philipps University Marburg Medical Center
Enrollment
29
Locations
1
Primary Endpoint
Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery
Status
Terminated
Last Updated
last year

Overview

Brief Summary

Recovery after the surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes. However, the content of these interventions needs further examination. This study aims to examine if the developed preoperative intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome and postoperative recovery. Therefore an online-tool has been developed. Using an online-approach makes it possible to reach many patients taking as little time and cost as possible.

Patients who undergo surgery in the next two weeks and want to participate in the study will be asked for the planned surgical procedure. There will be a filter (stratum) for surgery. Patients with the same kind of surgery are randomized into two groups (Control vs. intervention group) after they've filled some questionnaires at the baseline assessment. Following this, the intervention group will participate in the psychological online intervention (around 30 minutes). The intervention will focus on the treatment outcome expectations and personal control expectations to increase patients' positive expectations. The control group will receive no psychological intervention. Both groups will fill out questionnaires again in the evening, two days before the surgery, around one week after the surgery, and three months after the surgery.

Registry
clinicaltrials.gov
Start Date
June 15, 2021
End Date
November 24, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Winfried Rief

Professor, Dr.

Philipps University Marburg Medical Center

Eligibility Criteria

Inclusion Criteria

  • In-patient operation under general anesthetic
  • Age 18 or above
  • Fluency in German
  • Informed consent

Exclusion Criteria

  • Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
  • Emergency surgery

Outcomes

Primary Outcomes

Change in Pain Disability Index (PDI) from Baseline to two days pre-surgery to one week post-surgery to three months post-surgery

Time Frame: Baseline, up to one week post-surgery, up to three months post-surgery

Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome.

Secondary Outcomes

  • Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery(Baseline, up to one week post-surgery, up to three months post-surgery)
  • Change in The Control Attitudes Scale-Revised (CAS-R) from Baseline to one week post-surgery(Baseline, up to one week post-surgery)
  • Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery(Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery)
  • Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to two days pre-surgery to one week post-surgery(Baseline, two days pre-surgery, up to one week post-surgery, up to three months post-surgery)
  • Change in The Amsterdam Preoperative Anxiety and Information Scale (APAIS) from Baseline to two days pre-surgery(Baseline, two days pre-surgery)

Study Sites (1)

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