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Completed

NCT Number: NCT02236455

Effects of Complementary Therapies Delivered Via Mobile Technologies

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.

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Key information

Conditions

Acute Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Self Efficacy Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landspítala

Reykjavik, 101, Iceland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio Relaxation Technique

Behavioral

Audio relaxation technique created by an Icelandic Registered Nurse.

Other names: Guided Imagery

Medical Music Intervention

Behavioral

Audio recordings of non-lyrical relaxing music

Other names: Music Therapy

Nature Therapy without Music

Behavioral

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

Other names: Ecotherapy

Nature Therapy with Music

Behavioral

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

Other names: Ecotherapy with Music

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of San Francisco

Other

Collaborators

  • Fulbright

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2014
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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