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

Trauma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909882
• Other study ID #: Massage therapy
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: July 25, 2013
• Start date: August 2007
• Est. completion date: May 2013

Study information

• Verified date: August 2012
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Trauma

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Baqiyatallah Medical Sciences University	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Change in Systolic Blood Pressure	1 year	No
Secondary	Diastolic Blood Pressure	change in diastolic blood pressure	1 year	No
Secondary	Respiratory Rate	change in respiratory rate	1 year	No
Secondary	Pulse Rate	change in pulse rate	1 year	No
Secondary	Glasgow Coma Scale	change in Glasgow Coma Scale	1 year	No