<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821207</url>
  </required_header>
  <id_info>
    <org_study_id>2018/1357</org_study_id>
    <nct_id>NCT03821207</nct_id>
  </id_info>
  <brief_title>The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students</brief_title>
  <official_title>The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aydin Adnan Menderes University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aydin Adnan Menderes University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will planing to determine the advantages of abdominal massage and exercise on&#xD;
      primary dysmenorrhea in university students, and to evaluate whether one of these&#xD;
      applications is superior to the other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The students included in the study will be randomly separated into 3 groups using a&#xD;
      computer-based randomisation plan (www.randomization.com).&#xD;
&#xD;
      Those included in the massage group will be instructed to massage the abdomen for 10 mins a&#xD;
      day on the first 3 days of the menstrual cycle. The massage is to be applied as effleurage&#xD;
      (light touch) clockwise over the abdomen from over the abdominal wall to the intestinal area.&#xD;
&#xD;
      The students in the exercise group will be instructed to perform stretching exercises&#xD;
      including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual&#xD;
      cycle.&#xD;
&#xD;
      The control group will perform no exercise or massage. The applications will be demonstrated&#xD;
      to the participants by a physiotherapist. Throughout the study period, the students will be&#xD;
      followed up to ensure that the applications are being made. Follow-up of the applications of&#xD;
      abdominal massage and stretching exercises applied by there searcher physiotherapist&#xD;
      according to the study plan will be conducted by the researchers.&#xD;
&#xD;
      The participants will be informed how to apply the massage and perform the exercises and that&#xD;
      these applications will cause no side-effects. They will also be informed that participation&#xD;
      in the study is voluntary and they can withdraw from the study at any time.&#xD;
&#xD;
      The study will include volunteer female students, aged 18- 20 years, with regular menstrual&#xD;
      cycles, who record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3&#xD;
      menstrual cycles and will not use analgesics during the study.&#xD;
&#xD;
      Data Collection Tools Personal Information Form: This form was prepared by the researchers in&#xD;
      accordance with previous reports in literature to include 5 socio-demographic items and 14&#xD;
      items related to the menstrual history (age of menarche, frequency of painful menstruation,&#xD;
      amount of bleeding, family history of painful menstruation, methods of dealing with the pain,&#xD;
      etc).&#xD;
&#xD;
      Visual Analog Scale (VAS):This scale is a simple method used in the measurement of pain&#xD;
      severity and in the follow-up of pain. The patient is instructed to mark the severity of pain&#xD;
      on a 10cm horizontal line, where 0= non pain and 10= intolerable pain.&#xD;
&#xD;
      Dysmenorrhea Symptom List:This list was prepared by the researchers in accordance with&#xD;
      literature to evaluate the efficacy of the application and includes the findings seen in the&#xD;
      presence of dysmenorrhea in females. Each finding is scored from 0-3 as 0= non symptom, 1=&#xD;
      mild symptom that does not affect daily activity, 2 = mild non-debilitating symptom that&#xD;
      affects daily activity, 3= totally debilitating severe symptom.&#xD;
&#xD;
      Amount of Menstrual Blood: As it is impossible to measure blood lost during menstruation in a&#xD;
      laboratory environment, a pictorial blood loss evaluation table will be used,which is a&#xD;
      practical and low-cost method with a high accuracy rate. The pictorial blood loss evaluation&#xD;
      table was developed to show the degree of soiling. The participants will be given detailed&#xD;
      instructions of how to use these forms and will be checked as to whether or not they have&#xD;
      understood by being instructed to record a bleeding pattern described by the researchers (eg,&#xD;
      mark on the table that in the first 2 days you have used 5 pads completely soiled and in the&#xD;
      following 3 days, 2 half pads and 1 with staining). The pictorial index score is calculated&#xD;
      by giving points of 1, 5 and 20 to mild, moderately and heavily soiled pads respectively, and&#xD;
      scores of 1 and 5 for small and large clots. A cut-off value of 100 will be used. To reduce&#xD;
      misinterpretations resulting from the use of different pads, all the participants will be&#xD;
      recommended to use the same brand of sanitary pad.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomised Controlled Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain</measure>
    <time_frame>6 month</time_frame>
    <description>Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.</measure>
    <time_frame>6 month</time_frame>
    <description>Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding</measure>
    <time_frame>6 month</time_frame>
    <description>Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>The exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The abdominal massage group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will perform no exercise or massage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The exercise group</intervention_name>
    <description>The students will make exercise during the first three days of the menstrual period</description>
    <arm_group_label>The exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The abdominal massage group</intervention_name>
    <description>The students will make abdominal massage during the first three days of the menstrual period</description>
    <arm_group_label>The abdominal massage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>The students will nor massage or exercise</description>
    <arm_group_label>The control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the&#xD;
        last 3 menstrual cycles Not use analgesics during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary&#xD;
        system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies&#xD;
        Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months&#xD;
        Hormonal treatment in the last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meryem Kurek Eken</last_name>
    <role>Study Director</role>
    <affiliation>Aydin Adnan Menderes University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meryem Kurek Eken</name>
      <address>
        <city>Aydın</city>
        <zip>09013</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
    <investigator_full_name>Meryem Kurek eken</investigator_full_name>
    <investigator_title>Associated Proffesor</investigator_title>
  </responsible_party>
  <keyword>Abdominal massage</keyword>
  <keyword>Exercise</keyword>
  <keyword>Primary Dysmenorrhea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821207
org study id: 2018/1357
nct id: NCT03821207
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will planing to determine the advantages of abdominal massage and exercise on
      primary dysmenorrhea in university students, and to evaluate whether one of these
      applications is superior to the other.
The students included in the study will be randomly separated into 3 groups using a
      computer-based randomisation plan (www.randomization.com).

      Those included in the massage group will be instructed to massage the abdomen for 10 mins a
      day on the first 3 days of the menstrual cycle. The massage is to be applied as effleurage
      (light touch) clockwise over the abdomen from over the abdominal wall to the intestinal area.

      The students in the exercise group will be instructed to perform stretching exercises
      including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual
      cycle.

      The control group will perform no exercise or massage. The applications will be demonstrated
      to the participants by a physiotherapist. Throughout the study period, the students will be
      followed up to ensure that the applications are being made. Follow-up of the applications of
      abdominal massage and stretching exercises applied by there searcher physiotherapist
      according to the study plan will be conducted by the researchers.

      The participants will be informed how to apply the massage and perform the exercises and that
      these applications will cause no side-effects. They will also be informed that participation
      in the study is voluntary and they can withdraw from the study at any time.

      The study will include volunteer female students, aged 18- 20 years, with regular menstrual
      cycles, who record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3
      menstrual cycles and will not use analgesics during the study.

      Data Collection Tools Personal Information Form: This form was prepared by the researchers in
      accordance with previous reports in literature to include 5 socio-demographic items and 14
      items related to the menstrual history (age of menarche, frequency of painful menstruation,
      amount of bleeding, family history of painful menstruation, methods of dealing with the pain,
      etc).

      Visual Analog Scale (VAS):This scale is a simple method used in the measurement of pain
      severity and in the follow-up of pain. The patient is instructed to mark the severity of pain
      on a 10cm horizontal line, where 0= non pain and 10= intolerable pain.

      Dysmenorrhea Symptom List:This list was prepared by the researchers in accordance with
      literature to evaluate the efficacy of the application and includes the findings seen in the
      presence of dysmenorrhea in females. Each finding is scored from 0-3 as 0= non symptom, 1=
      mild symptom that does not affect daily activity, 2 = mild non-debilitating symptom that
      affects daily activity, 3= totally debilitating severe symptom.

      Amount of Menstrual Blood: As it is impossible to measure blood lost during menstruation in a
      laboratory environment, a pictorial blood loss evaluation table will be used,which is a
      practical and low-cost method with a high accuracy rate. The pictorial blood loss evaluation
      table was developed to show the degree of soiling. The participants will be given detailed
      instructions of how to use these forms and will be checked as to whether or not they have
      understood by being instructed to record a bleeding pattern described by the researchers (eg,
      mark on the table that in the first 2 days you have used 5 pads completely soiled and in the
      following 3 days, 2 half pads and 1 with staining). The pictorial index score is calculated
      by giving points of 1, 5 and 20 to mild, moderately and heavily soiled pads respectively, and
      scores of 1 and 5 for small and large clots. A cut-off value of 100 will be used. To reduce
      misinterpretations resulting from the use of different pads, all the participants will be
      recommended to use the same brand of sanitary pad.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomised Controlled Study
primary purpose: Treatment
masking: None (Open Label)
measure: The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain
time frame: 6 month
description: Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups
measure: The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.
time frame: 6 month
description: Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.
measure: The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding
time frame: 6 month
description: Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle
arm group label: The exercise group
arm group type: Active Comparator
description: The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle
arm group label: The abdominal massage group
arm group type: Active Comparator
description: The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen
arm group label: The control group
arm group type: Placebo Comparator
description: The control group will perform no exercise or massage.
intervention type: Behavioral
intervention name: The exercise group
description: The students will make exercise during the first three days of the menstrual period
arm group label: The exercise group
intervention type: Behavioral
intervention name: The abdominal massage group
description: The students will make abdominal massage during the first three days of the menstrual period
arm group label: The abdominal massage group
intervention type: Behavioral
intervention name: Control Group
description: The students will nor massage or exercise
arm group label: The control group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meryem Kurek Eken
role: Study Director
affiliation: Aydin Adnan Menderes University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aydin Adnan Menderes University
investigator full name: Meryem Kurek eken
investigator title: Associated Proffesor
mesh term: Dysmenorrhea