<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170124032147N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Olive Oil and Sweet Almonds  on the prevention of Bed Sore</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the  Effect of Massage of Olive Oil and Sweet Almond on prevention of Bed Sore in Hospitalized Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25123</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: To Randomize the method of enclosed envelopes used, Randomization description: The research samples were randomly assigned to the six-block questionnaire, which were performed by the software. Sixth permutations were determined using the three letters A for the control group, the letter B for the intervention group with olive oil and the letter C for the intervention group with sweet almond oil, and using the randomized method, six permutations in the triple groups were chosen, Blinding description: It should be noted that sweet almonds and olive oil were odorless, but they have differences in their concentration and color,   so blindness of researcher impossible.but these oils were placed in the dark bottle, so the patients were blindness. In this study double blindness (patients and analyzer the data ) were take place.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bed sore.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: The method of intervention were done as: every day, 1-3 ml of olive oil ( was made by Exir company) we used in order for gently massage in  the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change  position every 2 hours, and  using  wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil. Intervention 2: Second intervention group: The method of intervention were done as: every day, 1-3 ml of sweet almond oil (was made by Barij essence) we used in order for gently massage in  the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change  position every 2 hours, and  using  wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil. Intervention 3: control group: The control group,  just   giving   the   routine  treatment  such as, change  position every 2 hours, and  using  wavy mattress. Then, the incidence of bed sore and its grades will be investigated within one week.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Title: Comparison of the effect of massage of olive oil and sweet  almonds  oil on the prevention of bed sores


Back ground: Prevention  of  bed sore is a priority in the intensive care unit.  Bed sore is a complication that affects more than 1.3 million adults worldwide every year and  in developed countries, it has a prevalence of 3% to 30% and more than 1% to 50%. Wound healing is a long-term bed and also increases the time of admission and treatment costs , So preventing it is important. In this regard, one of the tasks of the nurses, as people who have the scientific and practical capabilities consistent  with  the  knowledge of the world today, Providing care at different levels of care is in the care of patients. One of the measures to prevent bed sores in the field of complementary medicine and traditional medicine is the use of medicinal herbs. These plants are available and not expensive and have no side effects. The aim of this study was to compare the effect of massage with olive oil and sweet almond on prevention of bed sore formation in ICU patients.




Materials and methods: In this double-blind randomized clinical trial Was performed  on 90 patients  that  hospitalized in ICU in Imam Jafar Sadeg Hospital. Patients were selected by purposive sampling method and were divided  into two intervention and one control groups.  During  a week, patients of the control group received their usual skin care including changing  positions every two hours and flow mattress while the patients of the intervention group received usual care in addition to daily use of  1-3ml (based on the area) of the olive oil or sweet almond was gently massageed into areas of the body. Data about pressure ulcers were collected using a demographic questionnaire and Braden's questionnaire. and was analyzed by chi-square test, Fisher’s exact test and variance analysis test in SPSS software version16.

.
Results: In the massage group with olive oil, 13.2% had first grade bedding and 3.3% had secondary grade ulcer and 83.5% had no bed sores. In the massage group with sweet almond oil, 16.6% had first grade bedding and 6.6% had secondary grade ulcer and 76.8% had no bed sores and  in the control group, 26.8% had first grade bedding and 13.2% had secondary grade ulcer and 60% had no bed ulcer. The results of this study showed that the incidence of bed  sore in the intervention groups was lower than the control group. Also, the incidence of  bed sore in the massage group with olive oil was lower than that of sweet almond oil massage group(pvalu&lt;0/001). 

 

Conclusion: The results of this study showed that there was a significant difference between the frequency distribution of  bed sore in intervention and control groups. It can be concluded that the use of olive oil and topical sweet almond oil is effective in preventing  bed sore in patients.

Key words:, Olive Oil, sweet almonds oil , Prevention, Bed Sore, Massage</results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Islami Hassan Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>(Nusrat East) Dr. Mirmohani Ave., Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 35 3232 9608</telephone>
        <email>b-ghafourzadeh@razi.tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery Medical Sciences of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Islami Hassan Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>(Nusrat East) Dr. Mirmohani Ave., Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 35 3232 9608</telephone>
        <email>b-ghafourzadeh@razi.tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients without Bed Sore
Inability to movement or to move only with an instrument</inclusion_criteria>
      <agemin>42 years</agemin>
      <agemax>93 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The possibility of any susceptibility to the use of Olive Oil or SweetAlmond oil
Patient dissatisfaction with collaboration in the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: The method of intervention were done as: every day, 1-3 ml of olive oil ( was made by Exir company) we used in order for gently massage in  the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change  position every 2 hours, and  using  wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil.</i_keyword>
      <i_keyword>Second intervention group: The method of intervention were done as: every day, 1-3 ml of sweet almond oil (was made by Barij essence) we used in order for gently massage in  the area like ears, scapula, spinal cord, lumbar, baettecks, cilia and sacrum, elbows , Heel and ankles. In deed the patients gave the nursing care like change  position every 2 hours, and  using  wavy mattress (routine nursing care in the ward). Then, the incidence of bed sore and its grades will be investigated within one week after using this oil.</i_keyword>
      <i_keyword>control group: The control group,  just   giving   the   routine  treatment  such as, change  position every 2 hours, and  using  wavy mattress. Then, the incidence of bed sore and its grades will be investigated within one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with bed sore  in Braden questionnaire. Timepoint: Before the intervention begins, every 24 hours for one week, immediately after the intervention. Method of measurement: Braden International Standard (Standard Instrument).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-19</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>(Nusrat East) Dr Mirkhani Ave., Tohid Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
