Acute PainNCT02236455
Effects of Complementary Therapies Delivered Via Mobile Technologies
A study testing Audio Relaxation Technique, Medical Music Intervention and Nature Therapy without Music in people with Acute Pain and Anxiety, run by University of San Francisco at 1 site in Iceland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Anxiety, Self Efficacy
- What is being tested?
- Audio Relaxation Technique, Medical Music Intervention and Nature Therapy without Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIceland
- Study dates
- Mar 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18-75-years
- English or Icelandic speaking
- Cognitively alert and oriented to person, place, time, and situation
- Intact visual and auditory senses
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Pain, Anxiety, Self Efficacy
- Being tested
- Audio Relaxation Technique, Medical Music Intervention, Nature Therapy without Music, Nature Therapy with Music
- Keywords
- complementary medicine, state anxiety, acute pain, self-efficacy, surgery, medical music intervention, nature therapy, relaxation technique
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio Relaxation TechniqueBehavioural
Also called Guided Imagery
Audio relaxation technique created by an Icelandic Registered Nurse.
Medical Music InterventionBehavioural
Also called Music Therapy
Audio recordings of non-lyrical relaxing music
Nature Therapy without MusicBehavioural
Also called Ecotherapy
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
Nature Therapy with MusicBehavioural
Also called Ecotherapy with Music
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
| Study group | Role | What they receive |
|---|---|---|
| Audio Relaxation technique | Experimental | 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. Receives: Behavioral: Audio Relaxation Technique |
| Medical Music Intervention | Experimental | Music intervention is use to assist with relaxation and reduce stress levels in patients. Receives: Behavioral: Medical Music Intervention |
| Nature Therapy without Music | Experimental | Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients. Receives: Behavioral: Nature Therapy without Music |
| Nature Therapy with Music | Experimental | Nature therapy videos were produced with and without music for surgical patients. Receives: Behavioral: Nature Therapy with Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ten days
Secondary outcomes (1)
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.
Measured: Ten Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Fulbright
- Responsible party
- Principal investigator, Margaret M. Hansen, University of San Francisco
- Investigators
- Margaret M Hansen, Ed.D., Principal investigator, University of San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236455
- Sponsor's protocol ID
- S5862
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19962104Kline GA. Does a view of nature promote relief from acute pain? J Holist Nurs. 2009 Sep;27(3):159-66. doi: 10.1177/0898010109336138.
PubMed 19755566Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
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.
PubMed 25888344
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02236455
- Acronym / sponsor ID
- S5862
- Conditions
- Acute Pain, Anxiety, Self Efficacy
- Keywords
- complementary medicine, state anxiety, acute pain, self-efficacy, surgery, medical music intervention, nature therapy, relaxation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of San FranciscoUniversity, hospital or other
- Collaborators
- Fulbright
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Audio Relaxation technique | Experimental | Behavioral: Audio Relaxation TechniqueRelaxation 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. |
| Medical Music Intervention | Experimental | Behavioral: Medical Music InterventionMusic intervention is use to assist with relaxation and reduce stress levels in patients. |
| Nature Therapy without Music | Experimental | Behavioral: Nature Therapy without MusicEcotherapy is the use of nature to reduce stress and to increase levels of well-being in patients. |
| Nature Therapy with Music | Experimental | Behavioral: Nature Therapy with MusicNature therapy videos were produced with and without music for surgical patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range 18-75-years
- English or Icelandic speaking
- Cognitively alert and oriented to person, place, time, and situation
- Intact visual and auditory senses
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio Relaxation TechniqueAlso: Guided ImageryAudio relaxation technique created by an Icelandic Registered Nurse. | Behavioural | Audio Relaxation technique |
| Medical Music InterventionAlso: Music TherapyAudio recordings of non-lyrical relaxing music | Behavioural | Medical Music Intervention |
| Nature Therapy without MusicAlso: EcotherapyNature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients | Behavioural | Nature Therapy without Music |
| Nature Therapy with MusicAlso: Ecotherapy with MusicNature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients | Behavioural | Nature Therapy with Music |
Primary outcome
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.
1 secondary outcome
Change in baseline pain level using the Numeric Rating Scale (NRS)
Time frame: Ten Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Results publication: PubMed 19962104Engwall 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 publication: PubMed 19755566Kline 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 publicationRoykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
- Derived from this study: PubMed 25888344Hansen 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.
- National Center for Complementary Medicine (NIH)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret M Hansen, Ed.D. principal investigator
University of San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio Relaxation Technique, Medical Music Intervention and Nature Therapy without Music in people with Acute Pain and Anxiety, run by University of San Francisco at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI) (time frame: Ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236455, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.