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

20 novembre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

41

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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:

-

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autres noms:
  • touche de guérison
  • tactile massage

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Qualitative interviews
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sense of coherence (SOC) scale
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Collaborateurs

Les enquêteurs

  • Directeur d'études: Torkel Falkenberg, PhD, Karolinska Institutet

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2012

Achèvement primaire (Réel)

1 janvier 2014

Achèvement de l'étude (Réel)

1 mai 2014

Dates d'inscription aux études

Première soumission

6 novembre 2015

Première soumission répondant aux critères de contrôle qualité

19 novembre 2015

Première publication (Estimation)

20 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Touch-ED

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur caring touch

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