Pregnancy ComplicationsNCT05980650
Reiki Effect on Risky Pregnants in Terms of Holistic Well-being, Prenatal, Maternal Attachment and Physical Symptoms
A study testing Reiki implication in people with Pregnancy Complications, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Reiki implication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 28th and above gestational week,
- Having been diagnosed with a risky pregnancy,
- Able to read and write, • Open to communication,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pregnancy Complications
- Being tested
- Reiki implication
- Keywords
- reiki, Holistic Well-being, Maternal Attachment, Physical Symptoms
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki implicationOther
Reiki will be implicate by researcher by putting hands on patient
| Study group | Role | What they receive |
|---|---|---|
| Reiki group | Experimental | 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 Receives: Other: Reiki implication |
| Routine Nursing Care | No intervention | This group will have just routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postpartum 6th weeks
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.
Measured: change in prenatal attachment in 4 weeks
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.
Measured: change in postpartum physical symptoms after giving a birth during 6 weeks
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.
Measured: change in maternal attachment in the postpartum period in the sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Keklik, Cukurova University
- Investigators
- Evşen Nazik, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980650
- Sponsor's protocol ID
- 135
- Status last verified
- Feb 2024
- First submitted
- 10 Jul 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept in confident
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05980650
- Acronym / sponsor ID
- 135
- Conditions
- Pregnancy Complications
- Keywords
- reiki, Holistic Well-being, Maternal Attachment, Physical Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki group | Experimental | Other: Reiki implicationReiki 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 |
| Routine Nursing Care | No intervention | –This group will have just routine nursing care given in the hospital during their hospitalization such as medical treatment implication and measuring vital signs |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 28th and above gestational week,
- Having been diagnosed with a risky pregnancy,
- Able to read and write, • Open to communication,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki implicationReiki will be implicate by researcher by putting hands on patient | Other | Reiki group |
Primary outcome
Reiki effect on risky pregnants in terms of holistic well-being
Time frame: postpartum 6th weeks
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
Time frame: change in prenatal attachment in 4 weeks
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
Time frame: change in postpartum physical symptoms after giving a birth during 6 weeks
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
Time frame: change in maternal attachment in the postpartum period in the sixth week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No. Data will be kept in confident
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evşen Nazik study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki implication in people with Pregnancy Complications, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reiki effect on risky pregnants in terms of holistic well-being (time frame: postpartum 6th weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.