NCT02610205

Brief Summary

The aim of this study was to explore participants´ subjective experiences and perspectives on pain and other factors of importance after an early nursing intervention consisting of "caring touch" (tactile massage and healing touch) for participants subjected to a motor vehicle accident with minor or no physical injuries.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 23, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

November 6, 2015

Last Update Submit

November 20, 2015

Conditions

Keywords

Caring touchTactile massageHealing touch

Outcome Measures

Primary Outcomes (2)

  • Qualitative interviews

    The interviews, which lasted up to 60 minutes, were conducted in Swedish, digitally recorded and transcribed verbatim by the investigator. An open-ended question was used to initiate the interviews. The interviews were analysed using Systematic Text Condensation (STC), based on Giorgi's psychological phenomenological analysis. The procedure consisted of the following steps: 1) An overview of the data was established, reading through all the interview transcripts; 2) A systematic review of the interviews was made line by line, identifying and sorting meaning units; 3) Meaning units were systematically abstracted and sorted into thematic code groups across individual participants; 4) data was synthesized from the thematic code groups to descriptions and concepts.

    Three months after inclusion

  • Visual analogue scale (VAS)

    The quantitative primary outcome was current level of pain measured by VAS, ranging from 0 (no pain) to 100 (worst imaginable pain). Participants rated their current VAS pain at baseline during the initial visit and before and after each treatment session with caring touch, and then again via a postal follow-up after six months. The VAS is a standard instrument for assessing pain that was feasible for the nurses to use in the emergency care setting.

    Change from baseline pain at 6 months

Secondary Outcomes (3)

  • Sense of coherence (SOC) scale

    Change from baselines sence of coherence at 6 months

  • Impact of Event Scale (IES-R)

    Change from baselines post traumatic stress at 6 months

  • The European Quality of Life (EQ-5D)

    Change from baselines quality of life at 6 months

Study Arms (1)

Caring touch interventions

The study was conducted as a mixed-methods design. A recruitment of potential study participants was made up from a list of incoming patients arriving at the emergency department following an MVA, and who upon medical examinations were given an injury severity score between 0-3 and subsequently discharged straight home. ISS is a 0-8 point scale rating injury severity, where a rating of 0 indicates no physical injury; 1-3 represents minor physical injuries. The patients were informed about the study by mail during the week after the MVA, and those interested in participating in the caring touch intervention were asked to contact the investigator and subsequently completed a written informed consent form during the first encounter with the therapist.

Other: caring touch

Interventions

The caring touch was adjusted to suit each participant and lasted for 20-60 minutes, once a week, for a maximum of eight treatment sessions altogether. The tactile massage, a soft tissue massage, without applying direct pressure or stretching to the muscles. The massage can be described as slow, gentle, structured, circulating movements with the palm of the therapist's hand, during which natural oil, or oil with the fragrance of lavender, was applied. The healing touch was based on an established procedure, during which the therapist applied a light pressure to the feet, ankles, knees, hips, stomach, heart area, arms, throat, forehead and scalp. The participant was fully dressed during the healing touch, as the therapist used her/his hand in different positions on the participant's body.

Also known as: healing touch, tactile massage
Caring touch interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A recruitment of potential study participants was made up from a list of incoming patients, arriving at the emergency department following an MVA, and who upon medical examinations were given an injury severity score (ISS) between 0-3 and subsequently discharged straight home. ISS is a 0-8 point scale rating injury severity, where a rating of 0 indicates no physical injury, 1-3 represents minor physical injuries; and 8 corresponds to a life-threatening injury

You may qualify if:

  • literate in Swedish and cognitively intact, arriving at the emergency department following an MVA, and who upon medical examinations were given an injury severity score (ISS) between 0-3 and subsequently discharged straight home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Airosa F, Arman M, Sundberg T, Ohlen G, Falkenberg T. Caring touch as a bodily anchor for patients after sustaining a motor vehicle accident with minor or no physical injuries - a mixed methods study. BMC Complement Altern Med. 2016 Mar 22;16:106. doi: 10.1186/s12906-016-1084-2.

MeSH Terms

Conditions

Emergencies

Interventions

Touch

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Torkel Falkenberg, PhD

    Karolinska Institutet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Manager of Nursing Development, Emergency Medicine

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 20, 2015

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

November 23, 2015

Record last verified: 2015-11