Effects of Complementary Therapies Delivered Via Mobile Technologies

NCT ID: NCT02236455

Last Updated: 2014-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Acute Pain Anxiety Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Audio Relaxation Technique

Intervention Type BEHAVIORAL

Audio relaxation technique created by an Icelandic Registered Nurse.

Medical Music Intervention

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

Group Type EXPERIMENTAL

Medical Music Intervention

Intervention Type BEHAVIORAL

Audio recordings of non-lyrical relaxing music

Nature Therapy without Music

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

Group Type EXPERIMENTAL

Nature Therapy without Music

Intervention Type BEHAVIORAL

Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients

Nature Therapy with Music

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

Group Type EXPERIMENTAL

Nature Therapy with Music

Intervention Type BEHAVIORAL

Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients

Interventions

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Audio Relaxation Technique

Audio relaxation technique created by an Icelandic Registered Nurse.

Intervention Type BEHAVIORAL

Medical Music Intervention

Audio recordings of non-lyrical relaxing music

Intervention Type BEHAVIORAL

Nature Therapy without Music

Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients

Intervention Type BEHAVIORAL

Nature Therapy with Music

Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients

Intervention Type BEHAVIORAL

Other Intervention Names

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Guided Imagery Music Therapy Ecotherapy Ecotherapy with Music

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fulbright

OTHER

Sponsor Role collaborator

University of San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Margaret M. Hansen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret M Hansen, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

University of San Francisco

Locations

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Landspítala

Reykjavik, , Iceland

Site Status

Countries

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Iceland

References

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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.

Reference Type RESULT
PMID: 19962104 (View on PubMed)

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.

Reference Type RESULT
PMID: 19755566 (View on PubMed)

Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 25888344 (View on PubMed)

Related Links

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http://nccam.nih.gov/

National Center for Complementary Medicine (NIH)

Other Identifiers

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S5862

Identifier Type: -

Identifier Source: org_study_id

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