xml: <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/NCT05980650</url>
    </required_header>
    <id_info>
      <org_study_id>135</org_study_id>
      <nct_id>NCT05980650</nct_id>
    </id_info>
    <brief_title>Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms</brief_title>
    <official_title>The Effect of Reiki Administered to Risky Pregnant Women on Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cukurova University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cukurova University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nurses should identify situations that may negatively affect mother-infant interaction from&#xD;
        the prenatal period and mothers who experience these situations in order to ensure the&#xD;
        establishment of secure attachment behavior. Then, they should cooperate with these mothers&#xD;
        to eliminate negative situations or reduce their effects. It is also stated that practices&#xD;
        such as meditation during pregnancy increase prenatal attachment.&#xD;
  &#xD;
        Despite the benefits of Reiki application, no study has been found on the use of reiki in&#xD;
        risky pregnant women. In this study, the effect of remotely applied reiki on high-risk&#xD;
        pregnant women on holistic well-being, prenatal, maternal attachment and physical symptoms&#xD;
        will be examined.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Complications that occur in risky pregnancies that are not followed up and treated at regular&#xD;
        intervals adversely affect maternal and fetal health, leading to outcomes that increase the&#xD;
        risk of mortality and morbidity. As a matter of fact, it is seen that maternal deaths&#xD;
        continue due to preventable or treatable causes during pregnancy or childbirth in the world&#xD;
        and in our country. In addition, approximately 380 women become pregnant every minute in the&#xD;
        world, half of them experience pregnancy-related complications and are classified in the&#xD;
        risky pregnancy group.&#xD;
  &#xD;
        The concept of well-being has emerged as a concept that further expands the views on health&#xD;
        and gathers various health fields under one roof. Well-being is a subjective data reached by&#xD;
        how individuals perceive their own lives. It is expressed in general judgments about affect&#xD;
        and life satisfaction that change from joy to depression.&#xD;
  &#xD;
        If pregnancy-related problems that negatively affect the perception of pregnancy are not&#xD;
        managed well, it can cause psychological distress and reduce the level of psychological&#xD;
        well-being of pregnant women. Psychological well-being is the positive psychological&#xD;
        functioning of mental health. It is also expressed as the frequency of experiencing good or&#xD;
        bad moods and emotions that have a positive or negative effect. Low level of psychological&#xD;
        well-being during pregnancy is associated with many risks such as negative pregnancy&#xD;
        outcomes, stress, anxiety, depression and behavioral problems in early childhood.&#xD;
  &#xD;
        Attachment is defined as an instinctive process that serves to maintain closeness to the&#xD;
        caregiver or as strong sensory bonds that people develop with people they deem important to&#xD;
        them. In an other saying; Attachment is defined as the emotional bond between the child and&#xD;
        his family. The tendency and need to establish emotional bonds are necessary for newborns to&#xD;
        survive. Attachment can be prenatal and maternal attachment . He defined the mother's love&#xD;
        for her baby during pregnancy and the bond she established with her as prenatal attachment.&#xD;
        Prenatal attachment and adaptation to motherhood affect the baby's healthier growth and&#xD;
        development and later on personality formation in childhood and adulthood. When there is a&#xD;
        secure attachment during pregnancy, the woman realizes that her unborn baby has a&#xD;
        relationship with her and sees her as a separate individual. This helps the expectant mother&#xD;
        to show love and affection to her baby, to protect her, to feed her, to show interest, to&#xD;
        interact and to be sensitive to her baby's needs, and facilitates the development of&#xD;
        motherhood identity and adaptation to motherhood. A healthy maternal attachment process&#xD;
        ensures a healthy communication between the mother and the baby, affects the baby's behavior&#xD;
        positively, and gives happiness to the mother. As health professionals, nurses play an&#xD;
        important role in the healthy development and maintenance of mother-infant attachment. If&#xD;
        mother-infant bonding is not successful, the baby may experience physical, emotional, social,&#xD;
        mental and language development problems. It is stated that the effects of secure or insecure&#xD;
        attachment for mother and baby can last a lifetime. Attachment disorders can cause emotional&#xD;
        disorders during pregnancy. In this respect, it is necessary to support expectant mothers&#xD;
        with risky pregnancies where attachment may be affected.&#xD;
  &#xD;
        The postpartum period is the harbinger of a new beginning for the woman and her family.&#xD;
        During this period, important anatomical, physiological, psychological and endocrine changes&#xD;
        are experienced in the mother's body. Depending on these changes, women experience a number&#xD;
        of physical symptoms. In studies examining the physical symptoms experienced by women in the&#xD;
        postpartum period; perineal problems, back pain, fatigue, pain in the incision/episiotomy&#xD;
        area, headache, edema, hemorrhoids, constipation, urinary incontinence, sleep disturbance,&#xD;
        sexual problems, painful coitus, and problems related to breastfeeding were determined to be&#xD;
        common.&#xD;
  &#xD;
        Reiki means &quot;universal life energy&quot;. It is this universal, primary and creative source of&#xD;
        power and energy that keeps us alive. Reiki is a natural healing energy. Reiki flows from the&#xD;
        practitioner's hands in a powerful and concentrated way, making use of light and energy. It&#xD;
        is a way of treating others physically and spiritually. Reiki focuses on energy chakras and&#xD;
        bio-psycho-spiritual healing. Reiki allows vital signs (blood pressure, pulse rate,&#xD;
        respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep,&#xD;
        reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces&#xD;
        the use of painkillers, increases coping skills and facilitate communication.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reiki effect on risky pregnants in terms of holistic well-being</measure>
      <time_frame>postpartum 6th weeks</time_frame>
      <description>Reiki may affect holistic well-being and holistic well-being scale points may be between 30 (minimum) and 300 (maximum) points in the postpartum 6th weeks. As the scale score approaches 300, holistic well-being increases and reaches a maximum at 300 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reiki effect on risky pregnants in terms of prenatal attachment</measure>
      <time_frame>change in prenatal attachment in 4 weeks</time_frame>
      <description>Reiki may affect prenatal attachment and prenatal attachment scale points may be between 21 and 84 during prenatal period in 4 weeks. As the scale score approaches 84, prenatal attachment increases and reaches a maximum at 84. The increase in the score indicates that the attachment level of the pregnant also increases.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reiki effect on risky pregnants in terms of postpartum physical symptoms</measure>
      <time_frame>change in postpartum physical symptoms after giving a birth during 6 weeks</time_frame>
      <description>Reiki may affect Postpartum Physical Symptom Severity which may be seen after giving a birth during 6 weeks. The minimum point is 0 and the maximum point is 54. It is expected to get score under 54 and close to 0 point from Postpartum Physical Symptom Severity Scale. The higher the score, the higher the postpartum physical symptom severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reiki effect on risky pregnants in terms of maternal attachment</measure>
      <time_frame>change in maternal attachment in the postpartum period in the sixth week</time_frame>
      <description>Reiki may affect maternal attachment and maternal attachment scale points may become higher than 26 in the postpartum period in the sixth week. The highest score that can be obtained from the scale is 104, and the lowest score is 26. High scores mean good maternal attachment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Pregnancy Complications</condition>
    <arm_group>
      <arm_group_label>Reiki group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Reiki will be implied to this group and this group will have routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine Nursing Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will have just routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Reiki implication</intervention_name>
      <description>Reiki will be implicate by researcher by putting hands on patient</description>
      <arm_group_label>Reiki group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  28th and above gestational week,&#xD;
  &#xD;
            -  Having been diagnosed with a risky pregnancy,&#xD;
  &#xD;
            -  Able to read and write, • Open to communication,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a psychiatric history,&#xD;
  &#xD;
            -  Multiple pregnancy&#xD;
  &#xD;
            -  Giving a birth to a child with a chronic illness&#xD;
  &#xD;
            -  Women who have received energy therapies and reiki training such as Reiki touch&#xD;
               therapy / Therapeutic touch / Healing touch before&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Risky pregnant women will be included in this study</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Evşen Nazik</last_name>
      <role>Study Director</role>
      <affiliation>Cukurova University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dilara Keklik</last_name>
      <phone>+905354924231</phone>
      <email>dkeklik@cu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Seda Karaçay Yıkar</last_name>
      <phone>+905416265614</phone>
      <email>syikar@cu.edu.tr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cukurova University</investigator_affiliation>
      <investigator_full_name>Dilara Keklik</investigator_full_name>
      <investigator_title>Research Assistant, PhD</investigator_title>
    </responsible_party>
    <keyword>reiki</keyword>
    <keyword>Holistic Well-being</keyword>
    <keyword>Maternal Attachment</keyword>
    <keyword>Physical Symptoms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pregnancy Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be kept in confident</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980650
  org study id: 135
  nct id: NCT05980650
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Nurses should identify situations that may negatively affect mother-infant interaction from
        the prenatal period and mothers who experience these situations in order to ensure the
        establishment of secure attachment behavior. Then, they should cooperate with these mothers
        to eliminate negative situations or reduce their effects. It is also stated that practices
        such as meditation during pregnancy increase prenatal attachment.
  
        Despite the benefits of Reiki application, no study has been found on the use of reiki in
        risky pregnant women. In this study, the effect of remotely applied reiki on high-risk
        pregnant women on holistic well-being, prenatal, maternal attachment and physical symptoms
        will be examined.
  Complications that occur in risky pregnancies that are not followed up and treated at regular
        intervals adversely affect maternal and fetal health, leading to outcomes that increase the
        risk of mortality and morbidity. As a matter of fact, it is seen that maternal deaths
        continue due to preventable or treatable causes during pregnancy or childbirth in the world
        and in our country. In addition, approximately 380 women become pregnant every minute in the
        world, half of them experience pregnancy-related complications and are classified in the
        risky pregnancy group.
  
        The concept of well-being has emerged as a concept that further expands the views on health
        and gathers various health fields under one roof. Well-being is a subjective data reached by
        how individuals perceive their own lives. It is expressed in general judgments about affect
        and life satisfaction that change from joy to depression.
  
        If pregnancy-related problems that negatively affect the perception of pregnancy are not
        managed well, it can cause psychological distress and reduce the level of psychological
        well-being of pregnant women. Psychological well-being is the positive psychological
        functioning of mental health. It is also expressed as the frequency of experiencing good or
        bad moods and emotions that have a positive or negative effect. Low level of psychological
        well-being during pregnancy is associated with many risks such as negative pregnancy
        outcomes, stress, anxiety, depression and behavioral problems in early childhood.
  
        Attachment is defined as an instinctive process that serves to maintain closeness to the
        caregiver or as strong sensory bonds that people develop with people they deem important to
        them. In an other saying; Attachment is defined as the emotional bond between the child and
        his family. The tendency and need to establish emotional bonds are necessary for newborns to
        survive. Attachment can be prenatal and maternal attachment . He defined the mother's love
        for her baby during pregnancy and the bond she established with her as prenatal attachment.
        Prenatal attachment and adaptation to motherhood affect the baby's healthier growth and
        development and later on personality formation in childhood and adulthood. When there is a
        secure attachment during pregnancy, the woman realizes that her unborn baby has a
        relationship with her and sees her as a separate individual. This helps the expectant mother
        to show love and affection to her baby, to protect her, to feed her, to show interest, to
        interact and to be sensitive to her baby's needs, and facilitates the development of
        motherhood identity and adaptation to motherhood. A healthy maternal attachment process
        ensures a healthy communication between the mother and the baby, affects the baby's behavior
        positively, and gives happiness to the mother. As health professionals, nurses play an
        important role in the healthy development and maintenance of mother-infant attachment. If
        mother-infant bonding is not successful, the baby may experience physical, emotional, social,
        mental and language development problems. It is stated that the effects of secure or insecure
        attachment for mother and baby can last a lifetime. Attachment disorders can cause emotional
        disorders during pregnancy. In this respect, it is necessary to support expectant mothers
        with risky pregnancies where attachment may be affected.
  
        The postpartum period is the harbinger of a new beginning for the woman and her family.
        During this period, important anatomical, physiological, psychological and endocrine changes
        are experienced in the mother's body. Depending on these changes, women experience a number
        of physical symptoms. In studies examining the physical symptoms experienced by women in the
        postpartum period; perineal problems, back pain, fatigue, pain in the incision/episiotomy
        area, headache, edema, hemorrhoids, constipation, urinary incontinence, sleep disturbance,
        sexual problems, painful coitus, and problems related to breastfeeding were determined to be
        common.
  
        Reiki means "universal life energy". It is this universal, primary and creative source of
        power and energy that keeps us alive. Reiki is a natural healing energy. Reiki flows from the
        practitioner's hands in a powerful and concentrated way, making use of light and energy. It
        is a way of treating others physically and spiritually. Reiki focuses on energy chakras and
        bio-psycho-spiritual healing. Reiki allows vital signs (blood pressure, pulse rate,
        respiratory rate) to reach normal levels, reduces acute and chronic pain, facilitates sleep,
        reduces anxiety and fear, relieves depression, reduces stress, provides relaxation, reduces
        the use of painkillers, increases coping skills and facilitate communication.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Reiki effect on risky pregnants in terms of holistic well-being
  time frame: postpartum 6th weeks
  description: Reiki may affect holistic well-being and holistic well-being scale points may be between 30 (minimum) and 300 (maximum) points in the postpartum 6th weeks. As the scale score approaches 300, holistic well-being increases and reaches a maximum at 300 points.
  measure: Reiki effect on risky pregnants in terms of prenatal attachment
  time frame: change in prenatal attachment in 4 weeks
  description: Reiki may affect prenatal attachment and prenatal attachment scale points may be between 21 and 84 during prenatal period in 4 weeks. As the scale score approaches 84, prenatal attachment increases and reaches a maximum at 84. The increase in the score indicates that the attachment level of the pregnant also increases.
  measure: Reiki effect on risky pregnants in terms of postpartum physical symptoms
  time frame: change in postpartum physical symptoms after giving a birth during 6 weeks
  description: Reiki may affect Postpartum Physical Symptom Severity which may be seen after giving a birth during 6 weeks. The minimum point is 0 and the maximum point is 54. It is expected to get score under 54 and close to 0 point from Postpartum Physical Symptom Severity Scale. The higher the score, the higher the postpartum physical symptom severity.
  measure: Reiki effect on risky pregnants in terms of maternal attachment
  time frame: change in maternal attachment in the postpartum period in the sixth week
  description: Reiki may affect maternal attachment and maternal attachment scale points may become higher than 26 in the postpartum period in the sixth week. The highest score that can be obtained from the scale is 104, and the lowest score is 26. High scores mean good maternal attachment.
  arm group label: Reiki group
  arm group type: Experimental
  description: Reiki will be implied to this group and this group will have routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs
  arm group label: Routine Nursing Care
  arm group type: No Intervention
  description: This group will have just routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs
  intervention type: Other
  intervention name: Reiki implication
  description: Reiki will be implicate by researcher by putting hands on patient
  arm group label: Reiki group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Risky pregnant women will be included in this study
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Evşen Nazik
  role: Study Director
  affiliation: Cukurova University
  last name: Dilara Keklik
  phone: +905354924231
  email: dkeklik@cu.edu.tr
  last name: Seda Karaçay Yıkar
  phone: +905416265614
  email: syikar@cu.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Cukurova University
  investigator full name: Dilara Keklik
  investigator title: Research Assistant, PhD
  mesh term: Pregnancy Complications
  sharing ipd: No
  ipd description: Data will be kept in confident