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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02236455
Other study ID # S5862
Secondary ID
Status Completed
Phase N/A
First received September 4, 2014
Last updated September 8, 2014
Start date March 2012
Est. completion date December 2012

Study information

Verified date September 2014
Source University of San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Audio Relaxation Technique
Audio relaxation technique created by an Icelandic Registered Nurse.
Medical Music Intervention
Audio recordings of non-lyrical relaxing music
Nature Therapy without Music
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
Nature Therapy with Music
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients

Locations

Country Name City State
Iceland Landspítala Reykjavik

Sponsors (2)

Lead Sponsor Collaborator
University of San Francisco Fulbright

Country where clinical trial is conducted

Iceland, 

References & Publications (3)

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. Review. — View 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. Review. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE) 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 No
Primary 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. Ten days No
Secondary 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. Ten Days No
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