Effect of Family Member's Massage Therapy on the Vital Signs and Glasgow Coma Scale Score

This study has been completed.
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier:
NCT01909882
First received: July 22, 2013
Last updated: July 25, 2013
Last verified: August 2012
  Purpose

The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized controlled Clinical Trial Study


Condition Intervention
Trauma
Other: Massage therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: The Effect of Family Members' Massage Therapy on Vital Signs and Glasgow Coma Scale Score of Patients Hospitalized in Intensive Care Unit: A Triple-blinded Randomized Controlled Clinical Trial Study

Resource links provided by NLM:


Further study details as provided by Baqiyatallah Medical Sciences University:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in Systolic Blood Pressure


Secondary Outcome Measures:
  • Diastolic Blood Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    change in diastolic blood pressure

  • Respiratory Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    change in respiratory rate

  • Pulse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    change in pulse rate

  • Glasgow Coma Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    change in Glasgow Coma Scale


Enrollment: 180
Study Start Date: August 2007
Study Completion Date: May 2013
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Family member's massage therapy
Family member's massage therapy
Other: Massage therapy
One session of massage therapy (for 60 minutes) was done by the patient's family member. Almond oil was used for effleurage and massage facilitation. Back, shoulder deltoid muscles, front and posterior parts of legs, arms, forearms, front and back parts of thighs, palms and fingers, metatarsus, front and back of feet and toes, belly and chest, auxiliaries and neck muscles of the patients were massaged. Massage techniques used included static massage, surface tension techniques, stretching massage, superficial lymph unload, transverse friction techniques, and myofacial releasing techniques. All the massage sessions were conducted in the morning shifts. For the control group, there was no intervention and patients just received the routine care of the unit.

Detailed Description:

Aims and objectives: To determine the effects of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit.

Background: Unalleviated complications related to hospitalization including stress, anxiety, pain, and fear can easily impacts on different systems including brain and stimulates sympatric nerves and as a result causes instabilities in vital signs and deterioration in consciousness level. Alternative and complementary therapies including therapeutic massage have been used to decrease the mentioned side effects.

Design: A Triple-blinded Randomized controlled Clinical Trial Methods: All prolonged hospitalized patients and their families (45 patients and 45 family members in each group) were selected consecutively among the patients admitted in ICU. Data collection tool consisted of two parts. The first part included demographic data (age, mar¬ital status and Body Max Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse rate). All measurements were conducted in same time in both groups as follow: before the intervention (the whole massage therapy), one hour, two hours, three hours, and four hours. Collected data was analyzed using descriptive and analytical statistics utilizing SPSS 11.5 software.

Keywords: Family member's massage therapy; Vital signs; Glasgow coma scale; Intensive care unit; Randomized controlled Clinical Trial; Iran.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • more than 10-day hospitalization, hemodynamic stability, having the Glasgow coma scale score between 7 to 12, intra cranial pressure less than 20 mmHg, no limitation or contraindication for changing in body position (including active bleeding or flail chest) and body massage (such as advanced burn degrees, severe dyspnea, fever, etc) and willing to participate in the study

Exclusion Criteria:

  • Any factors which violate inclusion criteria
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01909882

Locations
Iran, Islamic Republic of
Shariati hospital
Tehran, Iran, Islamic Republic of, 1956837173
Sponsors and Collaborators
Baqiyatallah Medical Sciences University
Tehran University of Medical Sciences
Investigators
Principal Investigator: amir vahedian-azimi, professor BMSU
  More Information

No publications provided

Responsible Party: Amir Vahedian-Azimi, Dr, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT01909882     History of Changes
Other Study ID Numbers: Massage therapy
Study First Received: July 22, 2013
Last Updated: July 25, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Baqiyatallah Medical Sciences University:
Family member's massage therapy
Vital signs
Glasgow coma scale
Intensive care unit
Randomized controlled Clinical Trial
Iran

ClinicalTrials.gov processed this record on September 18, 2014