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

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

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

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Other: Massage therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1956837173
    • Shariati Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Change in Systolic Blood Pressure	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure	change in diastolic blood pressure	1 year
Respiratory Rate	change in respiratory rate	1 year
Pulse Rate	change in pulse rate	1 year
Glasgow Coma Scale	change in Glasgow Coma Scale	1 year

Collaborators and Investigators

• Sponsor: Baqiyatallah Medical Sciences University
• Collaborators: Tehran University of Medical Sciences
• Investigators: Principal Investigator: amir vahedian-azimi, professor, BMSU

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Estimate): July 29, 2013
• Last Update Submitted That Met QC Criteria: July 25, 2013
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Intensive care unit; Vital signs; Iran; Glasgow coma scale; Family member's massage therapy; Randomized controlled Clinical Trial
• Other Study ID Numbers: Massage therapy