Effects of Complementary Therapies Delivered Via Mobile Technologies

September 8, 2014 updated by: Margaret M. Hansen, University of San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Reykjavik, Iceland, 101
        • Landspítala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Audio Relaxation technique
Relaxation is a process that decreases the effects of stress on your mind and body. Relaxation techniques can help you cope with everyday stress and with stress related to various health problems, such as cancer and pain.
Behavioral: Audio Relaxation Technique
Audio relaxation technique created by an Icelandic Registered Nurse.
Other Names:
  • Guided Imagery
Experimental: Medical Music Intervention
Music intervention is use to assist with relaxation and reduce stress levels in patients.
Behavioral: Medical Music Intervention
Audio recordings of non-lyrical relaxing music
Other Names:
  • Music Therapy
Experimental: Nature Therapy without Music
Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.
Behavioral: Nature Therapy without Music
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
Other Names:
  • Ecotherapy
Experimental: Nature Therapy with Music
Nature therapy videos were produced with and without music for surgical patients.
Behavioral: Nature Therapy with Music
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
Other Names:
  • Ecotherapy with Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Ten days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline pain level using the Numeric Rating Scale (NRS)
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.
Ten Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)
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.
Ten Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of San Francisco

Collaborators

Fulbright

Investigators

  • Principal Investigator: Margaret M Hansen, Ed.D., University of San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S5862

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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