Clinical trial NCT01909882: Effect of Family Member's Massage Therapy on the Vital Signs and Glasgow Coma Scale Score
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Family member's massage therapy
Vital signs
Glasgow coma scale
Intensive care unit
Randomized controlled Clinical Trial
Iran
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
First posted: 2013-07-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 year
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 1 year
measure: Respiratory Rate
timeFrame: 1 year
measure: Pulse Rate
timeFrame: 1 year
measure: Glasgow Coma Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati hospital
Study officials:
affiliation: BMSU
name: amir vahedian-azimi, professor
role: PRINCIPAL_INVESTIGATOR
References: