AnxietyNCT04935723
The Effects of Reiki on Abdominal Surgery Patients' Anxiety, Fear, Postoperative Pain and Life Findings
A study testing Reiki in people with Anxiety and Fear, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Abdominal surgeries are those in which pain is felt severely due to the incision close to the diaphragm and an intensive neural network in the abdominal area. If the patient's post-operative pain is not controlled; Since it will restrict patient mobility, it can cause problems on many systems such as the pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Fear, Postoperative Pain
- What is being tested?
- Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 25 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No vision-hearing problems Able to communicate verbally No diagnosed psychologist problems Has past or present don't use of substances who will receive general anesthesia, ASA I, II and III, Elective open abdominal surgery,
Who cannot join
- Patient Controlled Analgesia (PCA) use Those who have previously taken energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch who have had previous abdominal surgery,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cukurova University
Abdominal surgeries are those in which pain is felt severely due to the incision close to the diaphragm and an intensive neural network in the abdominal area. If the patient's post-operative pain is not controlled; Since it will restrict patient mobility, it can cause problems on many systems such as the pulmonary, cardiovascular and neuroendocrine system, and even suppress the immune system. Surgical intervention decision can cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of developing complications after surgery, pain, change in daily life activities, loss of social life and loss of control can lead to anxiety. In addition to all these, factors such as pain, fear, anxiety that stimulate the sympathetic nervous system can increase the pulse rate, blood pressure and respiratory rate.
Reiki, a complementary and alternative medicine (TAT) method, is a bioenergy based on the energy use of the body and has been used in various cultures for centuries in preventing and treating some diseases. Reiki is thought to help balance the body's natural energetic systems and reduce anxiety by transferring the available energy through hands. During Reiki, the activity of the parasympathetic system increases, pain and anxiety decrease. Thus, the patient's complaints are reduced by providing early discharge with possible complications after surgery.
Studies on the effectiveness of reiki, which is increasing worldwide use and recommended as a treatment approach for health services, are insufficient. The aim of this study, which is planned as a three-group interventional randomized control, is to examine the effect of reiki application on patients' negative reflections on pain, anxiety, fear and vital signs, which is the major surgery type in which patients experience the most pain.
Read the detailed description
In line with the results of the power analysis using the Gpower 3.1.9.2 program, it was planned to include 31 patients in reiki, 31 patients in sham reiki and 31 patients in the control group, and the simple randomization method was used to distribute the sample to the study groups. Research data were collected in a quiet single room in the operating room Pre-op Unit and in the patient rooms of General Surgery I and II Clinics between July 2020 and December 2020. In order to determine the clarity of the data collection form, after obtaining permission from the ethics committee and pre-application with 12 patients who met the study criteria, "Personal Information Form", "Patient Follow-up Form" and Postoperative Period Patient Analgesic Follow-up Form" and "Reiki-Related Feedback Form" were prepared. filled. Application" Data were collected before and after reiki in the Pre-op unit on the 0th day before the operation, and in the General Surgery I and II clinics on the 1st and 2nd days after the operation. After obtaining the consent of the patient in the preoperative unit, the Personal Information Form, the Surgical Fear Scale and the STAI-I State Anxiety Scale were applied, and the results and vital findings after SPO2 were recorded in the Patient Follow-up. Form. According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room and reiki/sham reiki was applied for approximately 25-30 minutes. Done. Reiki application was applied by a researcher who received Reiki II level training, and sham reiki was applied by a health professional who did not receive reiki training. A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions, areas of practice, sequence and times. 5 minutes after the end of the application, the "Surgical Fear Scale" and the "STAI-I State Anxiety Scale" were re-administered, the patient's SPO2 and vital signs were taken again. In the control group according to randomization. The "Surgical Fear Scale" and the "STAI-I State Anxiety Scale" were applied and the patient's vital signs and SPO2 were measured. 30 minutes from assessment. Then, all measurements were repeated and recorded on the Patient Follow-up Form.
On the 1st and 2nd postoperative days, 4 hours after the routine analgesic drug administration, pulse, respiratory rate, blood pressure and SPO2 were measured and recorded in the patient follow-up form. After assessing the severity of pain with the "Visual Comparison Scale" and the anxiety with the "STAI-I State Anxiety Inventory", the patient was evaluated once a day for 25-30 minutes, depending on the group he was in. minute reiki/sham reiki was applied. 5 minutes after the end of the application. Then, the patient's pulse, respiratory rate, blood pressure and SPO2 were measured again and recorded in the Patient Follow-up Form. The severity of pain was re-evaluated with the "Visual Comparison Scale" and the state anxiety level with the "STAI-I State Anxiety Inventory". The analgesic doses/numbers used on the 1st and 2nd days were recorded in the "Analgesic Usage Follow-up Form". Routine postoperative care was given to the control group without any intervention, and data collection tools were applied at the same time as the experimental group twice at 30-minute intervals. After the final evaluation on the 2nd day, Reiki and Sham Reiki were applied to the group, and the "Reiki Application Feedback Form" was applied.
Statistical analyzes were performed using a package program called SPSS (IBM SPSS Statistics 24). Frequency tables and descriptive statistics were used to interpret the findings. Parametric methods were used for measurement values suitable for normal distribution. The "Independent Sample-t" test (t-table value) was used and the "ANOVA" test (F-table value) method was used to compare the measurement values of two independent groups in accordance with parametric methods. Compare the measurement values of three or more independent groups. The "Paired Sample-t" test (t-table value) method was used to compare the measurement values of the two dependent groups. Non-parametric methods were used for the measurement values that did not fit the normal distribution. "Mann-Whitney U" test (Z-table value) and "Kruskal-Wallis H" test (χ2-table value) were used to compare the measured values of two independent groups in accordance with non-parametric methods. ) method was used to compare the measurement values of three or more independent groups. . The "Wilcoxon" test (Z-table value) method was used to compare the measurement values of the two dependent groups.
- Conditions
- Anxiety, Fear, Postoperative Pain, Reiki, Vital Signs
- Being tested
- Reiki
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
The study was conducted as a three-group interventional randomized controlled trial to examine the effect of Reiki touch therapy on surgical fear, pain, anxiety and vital signs in patients undergoing open abdominal surgery. Reiki was applied to the first group and sham reiki to the second group. Group 3 formed the control group.
| Study group | Role | What they receive |
|---|---|---|
| EFFECT OF REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | Experimental | According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room and reiki/sham reiki was applied for approximately 25-30 minutes. will be applied. Reiki application will be applied by a researcher who has Reiki I and Reiki II level training. Receives: Other: Reiki |
| EFFECT OF SHAM REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | Placebo comparator | According to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. Sham Reiki will be applied by a health professional who has not received Reiki training. Receives: Other: Reiki |
| ANXIETY, FEAR PAIN LEVELS AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | No intervention | The control group will be given routine post-operative care without any intervention and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Change of anxiety, fear, postoperative pain and vital signs of Reiki application before and after application.
Measured: 0-2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start15 Jun 2020
- Primary completion20 Nov 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Model description
- The study was planned as a three-group interventional randomized controlled study to examine the effect of Reiki touch therapy, which is a complementary method in relieving surgical fear, pain and anxiety in patients who will undergo open abdominal surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamide Sisman, Cukurova University
- Investigators
- Sevban Arslan, Phd, Study chair, Çukurova University Faculty of Health Sciences Adana, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935723
- Sponsor's protocol ID
- G-5097-2020
- Status last verified
- Mar 2022
- First submitted
- 10 Jun 2021
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The doctorate will be decided after the thesis defense
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cukurova University
- ClinicalTrials.gov ID
- NCT04935723
- Acronym / sponsor ID
- G-5097-2020
- Conditions
- Anxiety, Fear, Postoperative Pain, Reiki, Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 23 Jun 2021 (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.
Abdominal surgeries are those in which pain is felt severely due to the incision close to the diaphragm and an intensive neural network in the abdominal area. If the patient's post-operative pain is not controlled; Since it will restrict patient mobility, it can cause problems on many systems such as the pulmonary, cardiovascular and neuroendocrine system, and even suppress the immune system. Surgical intervention decision can cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of developing complications after surgery, pain, change in daily life activities, loss of social life and loss of control can lead to anxiety. In addition to all these, factors such as pain, fear, anxiety that stimulate the sympathetic nervous system can increase the pulse rate, blood pressure and respiratory rate.
Reiki, a complementary and alternative medicine (TAT) method, is a bioenergy based on the energy use of the body and has been used in various cultures for centuries in preventing and treating some diseases. Reiki is thought to help balance the body's natural energetic systems and reduce anxiety by transferring the available energy through hands. During Reiki, the activity of the parasympathetic system increases, pain and anxiety decrease. Thus, the patient's complaints are reduced by providing early discharge with possible complications after surgery.
Studies on the effectiveness of reiki, which is increasing worldwide use and recommended as a treatment approach for health services, are insufficient. The aim of this study, which is planned as a three-group interventional randomized control, is to examine the effect of reiki application on patients' negative reflections on pain, anxiety, fear and vital signs, which is the major surgery type in which patients experience the most pain.
Detailed description
In line with the results of the power analysis using the Gpower 3.1.9.2 program, it was planned to include 31 patients in reiki, 31 patients in sham reiki and 31 patients in the control group, and the simple randomization method was used to distribute the sample to the study groups. Research data were collected in a quiet single room in the operating room Pre-op Unit and in the patient rooms of General Surgery I and II Clinics between July 2020 and December 2020. In order to determine the clarity of the data collection form, after obtaining permission from the ethics committee and pre-application with 12 patients who met the study criteria, "Personal Information Form", "Patient Follow-up Form" and Postoperative Period Patient Analgesic Follow-up Form" and "Reiki-Related Feedback Form" were prepared. filled. Application" Data were collected before and after reiki in the Pre-op unit on the 0th day before the operation, and in the General Surgery I and II clinics on the 1st and 2nd days after the operation. After obtaining the consent of the patient in the preoperative unit, the Personal Information Form, the Surgical Fear Scale and the STAI-I State Anxiety Scale were applied, and the results and vital findings after SPO2 were recorded in the Patient Follow-up. Form. According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room and reiki/sham reiki was applied for approximately 25-30 minutes. Done. Reiki application was applied by a researcher who received Reiki II level training, and sham reiki was applied by a health professional who did not receive reiki training. A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions, areas of practice, sequence and times. 5 minutes after the end of the application, the "Surgical Fear Scale" and the "STAI-I State Anxiety Scale" were re-administered, the patient's SPO2 and vital signs were taken again. In the control group according to randomization. The "Surgical Fear Scale" and the "STAI-I State Anxiety Scale" were applied and the patient's vital signs and SPO2 were measured. 30 minutes from assessment. Then, all measurements were repeated and recorded on the Patient Follow-up Form.
On the 1st and 2nd postoperative days, 4 hours after the routine analgesic drug administration, pulse, respiratory rate, blood pressure and SPO2 were measured and recorded in the patient follow-up form. After assessing the severity of pain with the "Visual Comparison Scale" and the anxiety with the "STAI-I State Anxiety Inventory", the patient was evaluated once a day for 25-30 minutes, depending on the group he was in. minute reiki/sham reiki was applied. 5 minutes after the end of the application. Then, the patient's pulse, respiratory rate, blood pressure and SPO2 were measured again and recorded in the Patient Follow-up Form. The severity of pain was re-evaluated with the "Visual Comparison Scale" and the state anxiety level with the "STAI-I State Anxiety Inventory". The analgesic doses/numbers used on the 1st and 2nd days were recorded in the "Analgesic Usage Follow-up Form". Routine postoperative care was given to the control group without any intervention, and data collection tools were applied at the same time as the experimental group twice at 30-minute intervals. After the final evaluation on the 2nd day, Reiki and Sham Reiki were applied to the group, and the "Reiki Application Feedback Form" was applied.
Statistical analyzes were performed using a package program called SPSS (IBM SPSS Statistics 24). Frequency tables and descriptive statistics were used to interpret the findings. Parametric methods were used for measurement values suitable for normal distribution. The "Independent Sample-t" test (t-table value) was used and the "ANOVA" test (F-table value) method was used to compare the measurement values of two independent groups in accordance with parametric methods. Compare the measurement values of three or more independent groups. The "Paired Sample-t" test (t-table value) method was used to compare the measurement values of the two dependent groups. Non-parametric methods were used for the measurement values that did not fit the normal distribution. "Mann-Whitney U" test (Z-table value) and "Kruskal-Wallis H" test (χ2-table value) were used to compare the measured values of two independent groups in accordance with non-parametric methods. ) method was used to compare the measurement values of three or more independent groups. . The "Wilcoxon" test (Z-table value) method was used to compare the measurement values of the two dependent groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study was planned as a three-group interventional randomized controlled study to examine the effect of Reiki touch therapy, which is a complementary method in relieving surgical fear, pain and anxiety in patients who will undergo open abdominal surgery.
| Arm | Type | Receives |
|---|---|---|
| EFFECT OF REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | Experimental | Other: ReikiAccording to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room and reiki/sham reiki was applied for approximately 25-30 minutes. will be applied. Reiki application will be applied by a researcher who has Reiki I and Reiki II level training. |
| EFFECT OF SHAM REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | Placebo comparator | Other: ReikiAccording to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. Sham Reiki will be applied by a health professional who has not received Reiki training. |
| ANXIETY, FEAR PAIN LEVELS AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS | No intervention | –The control group will be given routine post-operative care without any intervention and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No vision-hearing problems Able to communicate verbally No diagnosed psychologist problems Has past or present don't use of substances who will receive general anesthesia, ASA I, II and III, Elective open abdominal surgery,
Key exclusion criteria (1 listed)
- Patient Controlled Analgesia (PCA) use Those who have previously taken energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch who have had previous abdominal surgery,
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 |
|---|---|---|
| ReikiThe study was conducted as a three-group interventional randomized controlled trial to examine the effect of Reiki touch therapy on surgical fear, pain, anxiety and vital signs in patients undergoing open abdominal surgery. Reiki was applied to the first group and sham reiki to the second group. Group 3 formed the control group. | Other | EFFECT OF REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS, EFFECT OF SHAM REIKIN ON ANXIETY, FEAR, PAIN AND LIFE FINDINGS OF ABDOMINAL SURGERY PATIENTS |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 0-2 day
Change of anxiety, fear, postoperative pain and vital signs of Reiki application before and after application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: Undecided. The doctorate will be decided after the thesis defense
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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.
Sevban Arslan, Phd study chair
Çukurova University Faculty of Health Sciences Adana, Turkey
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 in people with Anxiety and Fear, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 0-2 day). 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 10 Mar 2022.