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N/A Completed N=300 Randomized Double-blind Treatment

The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients

Source: ClinicalTrials.gov NCT01733771 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety — -2.83; 0.24; -1.99 units on VAS-A scale

Summary

This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.

Outcome Measures

OutcomeResultp-value
PRIMARY
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
-2.83; 0.24; -1.99

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18 years
  • Undergoing Laparoscopic Cholecysyectomy (LC)

Exclusion criteria

  • Patients with a history of obstructive sleep apnea
  • Contraindication for benzodiazepines
  • Hemodynamic instability
  • Leg ulcers
  • Patients undergoing a LC together with another surgical procedure.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01733771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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