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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Turkey (Türkiye)1 site
  • Adana City Hospital

    Sariçam, Sa, 01330

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05980650
Study groupRoleWhat they receive
Reiki groupExperimentalReiki 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 CareNo interventionThis 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted8 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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)
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

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.

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