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Clinical Trials/NCT02236455
NCT02236455
Completed
Not Applicable

Effects of Complementary Therapies Delivered Via Mobile Technologies on Surgical Patients' Reports of Anxiety, Pain, and Self-Efficacy in Healing: A Pilot Randomized Controlled Trial in Iceland

University of San Francisco1 site in 1 country105 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Pain
Sponsor
University of San Francisco
Enrollment
105
Locations
1
Primary Endpoint
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.

Detailed Description

Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may result in increased perceptions of pain and lower self-efficacy in healing. Complementary therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have been shown to benefit patients undergoing surgery. The aim of this study was to examine the effects of audio relaxation technique (ART), music intervention (MI), nature video application with music (NVAM), and nature video application without music (NVA) delivered via mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy in healing. Methods A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self-efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
December 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret M. Hansen

Associate Professor

University of San Francisco

Eligibility Criteria

Inclusion Criteria

  • Age range 18-75-years
  • English or Icelandic speaking
  • Cognitively alert and oriented to person, place, time, and situation
  • Intact visual and auditory senses

Exclusion Criteria

  • History of substance abuse
  • Chronic pain lasting more than six months
  • Use of narcotic medication for more than six months
  • Major psychiatric disorders
  • Taking prescribed medications for thought disorders
  • Having ophthalmology and/or auditory surgery or impairments

Outcomes

Primary Outcomes

Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)

Time Frame: Ten days

A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self- efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

Secondary Outcomes

  • Change in baseline pain level using the Numeric Rating Scale (NRS)(Ten Days)

Study Sites (1)

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