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Effects of Complementary Therapies Delivered Via Mobile Technologies

Primary Purpose

Acute Pain, Anxiety, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Audio Relaxation Technique
Medical Music Intervention
Nature Therapy without Music
Nature Therapy with Music
Sponsored by
University of San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Pain focused on measuring complementary medicine, state anxiety, acute pain, self-efficacy, surgery, medical music intervention, nature therapy, relaxation technique

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Landspítala

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Audio Relaxation technique

Medical Music Intervention

Nature Therapy without Music

Nature Therapy with Music

Arm Description

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.

Music intervention is use to assist with relaxation and reduce stress levels in patients.

Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.

Nature therapy videos were produced with and without music for surgical patients.

Outcomes

Primary Outcome Measures

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

Change in baseline pain level using the Numeric Rating Scale (NRS)
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.

Full Information

First Posted
September 4, 2014
Last Updated
September 8, 2014
Sponsor
University of San Francisco
Collaborators
Fulbright
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1. Study Identification

Unique Protocol Identification Number
NCT02236455
Brief Title
Effects of Complementary Therapies Delivered Via Mobile Technologies
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of San Francisco
Collaborators
Fulbright

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Anxiety, Self Efficacy
Keywords
complementary medicine, state anxiety, acute pain, self-efficacy, surgery, medical music intervention, nature therapy, relaxation technique

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Audio Relaxation technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical Music Intervention
Arm Type
Experimental
Arm Description
Music intervention is use to assist with relaxation and reduce stress levels in patients.
Arm Title
Nature Therapy without Music
Arm Type
Experimental
Arm Description
Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.
Arm Title
Nature Therapy with Music
Arm Type
Experimental
Arm Description
Nature therapy videos were produced with and without music for surgical patients.
Intervention Type
Behavioral
Intervention Name(s)
Audio Relaxation Technique
Other Intervention Name(s)
Guided Imagery
Intervention Description
Audio relaxation technique created by an Icelandic Registered Nurse.
Intervention Type
Behavioral
Intervention Name(s)
Medical Music Intervention
Other Intervention Name(s)
Music Therapy
Intervention Description
Audio recordings of non-lyrical relaxing music
Intervention Type
Behavioral
Intervention Name(s)
Nature Therapy without Music
Other Intervention Name(s)
Ecotherapy
Intervention Description
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
Intervention Type
Behavioral
Intervention Name(s)
Nature Therapy with Music
Other Intervention Name(s)
Ecotherapy with Music
Intervention Description
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
Primary Outcome Measure Information:
Title
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)
Description
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.
Time Frame
Ten days
Secondary Outcome Measure Information:
Title
Change in baseline pain level using the Numeric Rating Scale (NRS)
Description
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.
Time Frame
Ten Days
Other Pre-specified Outcome Measures:
Title
Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)
Description
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.
Time Frame
Ten Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret M Hansen, Ed.D.
Organizational Affiliation
University of San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landspítala
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19962104
Citation
Engwall M, Duppils GS. Music as a nursing intervention for postoperative pain: a systematic review. J Perianesth Nurs. 2009 Dec;24(6):370-83. doi: 10.1016/j.jopan.2009.10.013.
Results Reference
result
PubMed Identifier
19755566
Citation
Kline GA. Does a view of nature promote relief from acute pain? J Holist Nurs. 2009 Sep;27(3):159-66. doi: 10.1177/0898010109336138.
Results Reference
result
Citation
Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
Results Reference
result
PubMed Identifier
25888344
Citation
Hansen MM. A feasibility pilot study on the use of complementary therapies delivered via mobile technologies on Icelandic surgical patients' reports of anxiety, pain, and self-efficacy in healing. BMC Complement Altern Med. 2015 Mar 28;15:92. doi: 10.1186/s12906-015-0613-8.
Results Reference
derived
Links:
URL
http://nccam.nih.gov/
Description
National Center for Complementary Medicine (NIH)

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Effects of Complementary Therapies Delivered Via Mobile Technologies

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