search
Back to results

Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms

Primary Purpose

Pregnancy Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reiki implication
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy Complications focused on measuring reiki, Holistic Well-being, Maternal Attachment, Physical Symptoms

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 28th and above gestational week, Having been diagnosed with a risky pregnancy, Able to read and write, • Open to communication, Exclusion Criteria: Having a psychiatric history, Multiple pregnancy Giving a birth to a child with a chronic illness Women who have received energy therapies and reiki training such as Reiki touch therapy / Therapeutic touch / Healing touch before

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Reiki group

    Routine Nursing Care

    Arm 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

    This group will have just routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs

    Outcomes

    Primary Outcome Measures

    Reiki effect on risky pregnants in terms of holistic well-being
    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.
    Reiki effect on risky pregnants in terms of prenatal attachment
    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.
    Reiki effect on risky pregnants in terms of postpartum physical symptoms
    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.
    Reiki effect on risky pregnants in terms of maternal attachment
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 10, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Cukurova University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05980650
    Brief Title
    Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cukurova University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy Complications
    Keywords
    reiki, Holistic Well-being, Maternal Attachment, Physical Symptoms

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reiki group
    Arm Type
    Experimental
    Arm 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 Title
    Routine Nursing Care
    Arm Type
    No Intervention
    Arm 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(s)
    Reiki implication
    Intervention Description
    Reiki will be implicate by researcher by putting hands on patient
    Primary Outcome Measure Information:
    Title
    Reiki effect on risky pregnants in terms of holistic well-being
    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.
    Time Frame
    postpartum 6th weeks
    Title
    Reiki effect on risky pregnants in terms of prenatal attachment
    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.
    Time Frame
    change in prenatal attachment in 4 weeks
    Title
    Reiki effect on risky pregnants in terms of postpartum physical symptoms
    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.
    Time Frame
    change in postpartum physical symptoms after giving a birth during 6 weeks
    Title
    Reiki effect on risky pregnants in terms of maternal attachment
    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.
    Time Frame
    change in maternal attachment in the postpartum period in the sixth week

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Risky pregnant women will be included in this study
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 28th and above gestational week, Having been diagnosed with a risky pregnancy, Able to read and write, • Open to communication, Exclusion Criteria: Having a psychiatric history, Multiple pregnancy Giving a birth to a child with a chronic illness Women who have received energy therapies and reiki training such as Reiki touch therapy / Therapeutic touch / Healing touch before
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dilara Keklik
    Phone
    +905354924231
    Email
    dkeklik@cu.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seda Karaçay Yıkar
    Phone
    +905416265614
    Email
    syikar@cu.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Evşen Nazik
    Organizational Affiliation
    Cukurova University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be kept in confident

    Learn more about this trial

    Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms

    We'll reach out to this number within 24 hrs