Effects of Complementary Therapies Delivered Via Mobile Technologies

Study Overview
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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.

Official Title
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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

Conditions
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Anxiety, Acute Pain, Self Efficacy

Intervention / Treatment
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* Behavioral: Audio Relaxation Technique
* Behavioral: Medical Music Intervention
* Behavioral: Nature Therapy without Music
* Behavioral: Nature Therapy with Music


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Audio Relaxation technique<br>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<br>* Audio relaxation technique created by an Icelandic Registered Nurse.<br>* Other names: Guided Imagery;|
| Experimental: Medical Music Intervention<br>Music intervention is use to assist with relaxation and reduce stress levels in patients. | Behavioral: Medical Music Intervention<br>* Audio recordings of non-lyrical relaxing music<br>* Other names: Music Therapy;|
| Experimental: Nature Therapy without Music<br>Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients. | Behavioral: Nature Therapy without Music<br>* Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients<br>* Other names: Ecotherapy;|
| Experimental: Nature Therapy with Music<br>Nature therapy videos were produced with and without music for surgical patients. | Behavioral: Nature Therapy with Music<br>* Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients<br>* Other names: Ecotherapy with Music;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nature therapy, relaxation technique, complementary medicine, state anxiety, acute pain, self-efficacy, surgery, medical music intervention