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Caring Touch as a Bodily Anchor for Patients After Sustaining a Motor Vehicle Accident

20 novembre 2015 aggiornato da: Fanny Airosa

Integrative Care at the Emergency Department

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study was conducted as a longitudinal study, combining qualitative and quantitative perspectives, i.e. a mixed-methods design. The rationale for combining quantitative and qualitative methods was to provide a comprehensive exploration of the research question.Investigators conducted the interviews in a closed meeting room at the hospital, three months after the participant´s first hospital visit. The time span was set to allow the participants to conclude their treatments with caring touch. The interviews, which lasted up to 60 minutes, were conducted in Swedish, digitally recorded and transcribed verbatim by the investigators. An open-ended question was used to initiate the interviews. 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. Secondary exploratory outcomes were sense of coherence (SOC), constructed by Antonovsky on the basis of a salutogenic model. The Sense of Coherence scale was of interest since this instrument capture the participants' experiences of comprehensibility, manageability, and meaningfulness which we assumed could be linked to participant recovery. SOC, a 13-item rating scale, developed using the subscales of comprehensibility, manageability, and meaningfulness. Total scores of 21-59 indicate low sense of coherence, 60-74 an average sense of coherence, and 75-91 high sense of coherence. Additionally, the Impact of Event Scale (IES-R) has been well used in previous trauma research and was decided as being an appropriate tool to explore to what extent the participants experienced post-traumatic stress disease. IES-R, 22-item scale shows the degree to which the traumatic experience is felt on a consciousness level, and if the person exhibits avoidant behaviour. The IES-R is based on a 4-point frequency scales (i.e., 0=not at all, 1= a little bit, 2= moderately, 3=quite a bit, and 4=extremely). An average of the total scale sum of 1.8-2.0 indicates post-traumatic stress disorder. The IES-R seems to be a solid measure of post-traumatic phenomena that can augment related assessment approaches in clinical and research contexts. The European Quality of Life (EQ-5D) instrument was employed to explore participants´ health-related quality of life and self-related health. The EQ-5D instrument was selected because of the short-form and that it has been widely used to measure quality of life among the County Councils of Sweden. EQ-5D is a standardized instrument for measuring health outcome. Participants classify their health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels of severity: (1) no problems, (2) moderate problems, and (3) severe problems. From the sum a number of total 243 combinations of health can be created. Each health combination generates an index value from -0.59 to 1.0, where 1.0 indicates full health. Additionally, the EQ-5D has a visual analogue scale for self-rated health with the anchors at zero (worst imaginable health) up to 100 (best imaginable health).

Data from VAS pain ratings and questionnaires was manually transferred from paper into an electronic database before statistical analysis. Summary characteristics of participants were presented as proportions, mean, median, standard deviation and/or min-max values. Change scores of VAS pain ratings, SOC, IES-R and EQ-5D over time between baseline and follow-up after six months were analysed for patients with complete data. Considering rating scales and ordinal types of data, and the relatively small sample sizes, non-parametric statistical analysis, i.e. the Wilcoxon signed-rank test was employed for assessing change scores over time. All p-value calculations were conducted with a 5% significance level. An additional descriptive analysis was conducted for VAS pain ratings before and after each treatment session with caring touch. Computational software included STATA 13, StataCorp, USA and Microsoft Excel 2011, Microsoft, USA.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

41

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
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.
Altri nomi:
  • tocco curativo
  • tactile massage

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Qualitative interviews
Lasso di tempo: Three months after inclusion
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)
Lasso di tempo: Change from baseline pain at 6 months
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sense of coherence (SOC) scale
Lasso di tempo: Change from baselines sence of coherence at 6 months
The Sense of Coherence scale was of interest since this instrument capture the participants' experiences of comprehensibility, manageability, and meaningfulness which we assumed could be linked to participants recovery. SOC, a 13-item rating scale, developed using the subscales of comprehensibility, manageability, and meaningfulness. Total scores of 21-59 indicate low sense of coherence, 60-74 an average sense of coherence, and 75-91 high sense of coherence
Change from baselines sence of coherence at 6 months
Impact of Event Scale (IES-R)
Lasso di tempo: Change from baselines post traumatic stress at 6 months
The Impact of Event Scale has been well used in previous trauma research and was decided as being an appropriate tool to explore to what extent the participants experienced post-traumatic stress disease. IES-R, 22-item scale shows the degree to which the traumatic experience is felt on a consciousness level, and if the person exhibits avoidant behaviour. The IES-R is based on a 4-point frequency scales (i.e., 0=not at all, 1= a little bit, 2= moderately, 3=quite a bit, and 4=extremely). An average of the total scale sum of 1.8-2.0 indicates post-traumatic stress disorder. The IES-R seems to be a solid measure of post-traumatic phenomena that can augment related assessment approaches in clinical and research contexts.
Change from baselines post traumatic stress at 6 months
The European Quality of Life (EQ-5D)
Lasso di tempo: Change from baselines quality of life at 6 months
The European Quality of Life (EQ-5D) instrument was employed to explore participants´ health-related quality of life and self-related health. The EQ-5D instrument was selected because of the short-form and that it has been widely used to measure quality of life among the County Councils of Sweden. EQ-5D is a standardized instrument for measuring health outcome. Participants classify their health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels of severity: (1) no problems, (2) moderate problems, and (3) severe problems. From the sum a number of total 243 combinations of health can be created. Each health combination generates an index value from -0.59 to 1.0, where 1.0 indicates full health. Additionally, the EQ-5D has a visual analogue scale for self-rated health with the anchors at zero (worst imaginable health) up to 100 (best imaginable health).
Change from baselines quality of life at 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Direttore dello studio: Torkel Falkenberg, PhD, Karolinska Institutet

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2012

Completamento primario (Effettivo)

1 gennaio 2014

Completamento dello studio (Effettivo)

1 maggio 2014

Date di iscrizione allo studio

Primo inviato

6 novembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

19 novembre 2015

Primo Inserito (Stima)

20 novembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 novembre 2015

Ultimo verificato

1 novembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Touch-ED

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su caring touch

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