MassageNCT05113992
The Effect of Back Massage Before the Cardiac Electrophysiological Procedure
A study testing aromatherapy massage and classic massage in people with Massage, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of back massage with 4% frankincense and myrrh oil on back pain severity and comfort in patients who will undergo cardiac electrophysiological study (EPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massage
- What is being tested?
- aromatherapy massage and classic massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2020to 20 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are over 18 years old;
- agreeing to participate in the study;
- EPS planned from the femoral region;
- no communication problems (hearing, vision, speech, perception problems);
- According to VAS, there is no pain in any part of the body before the procedure;
- individuals who did not develop any reaction 30 minutes after applying the oils to be used on the skin on the forearm were included in the study.
Who cannot join
- Those who had an allergic skin reaction,
- skin disease in the back region,
- a history of fractures or surgical operations in the waist and back region in the last year,
- those who had neurological disorders (hemiparesis, etc.),
- those who received massage therapy in the last three months, those who were diagnosed with cancer,
- those who suffered from acute myocardial infarction were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Back Massage With Frankincense and Myrrh Oil Before the Cardiac Electrophysiological Procedure on Back Pain Intensity and Comfort
This study was conducted to determine the effect of back massage with 4% frankincense and myrrh oil on back pain severity and comfort in patients who will undergo cardiac electrophysiological study (EPS).
Read the detailed description
The study was conducted as a randomized controlled study. The population of the research consists of individuals who will undergo cardiac EPS in the angio unit of a heart hospital at a university. The sample size was determined as 20 people per group and a total of 60 people for an effect size of 0.131 and a power of 90%. Considering that there may be sample losses, 10 more patients were taken per group, and the study was completed with 30 patients for each group, a total of 90 people.
Randomization: Patients who met the inclusion criteria; They were assigned to one of three groups: 1. Intervention group massaged with frankincense and myrrh oil, 2. Placebo group massaged with jojoba oil, and 3. Control group. In hospital routine, patient appointments for the EPS procedure are determined on a weekly basis. Since the operation day of the research doctor who will perform the EPS procedure is Monday; Since patient rooms are not single occupancy; In addition, groups were randomized computer according to weeks to prevent contamination of frankincense and myrrh oil used for massage in the intervention group to the placebo and control groups.
Data were collected with the Patient Information Form, which includes the sociodemographic and health history of the individuals, the Visual Analogue Scale (VAS) for pain severity assessment, and the General comfort questionary (GCQ) for comfort.
Individuals who met the inclusion criteria in the study were assigned to the 1st Intervention group, 2nd Placebo group, and 3rd Control group in accordance with randomization, with their informed consent. No intervention was made in the standard treatment applied in the clinic.
In a systematic review and meta-analysis study, it is reported that bed rest is recommended for patients at wide intervals from 2 hours to 24 hours (2,4,6,12 and 24 hours) to prevent vascular complications after cardiac catheterization.Therefore, in this study, post-procedure back pain and comfort assessment were checked at the 4th hour, which is the clinical ambulation routine.
Interventions applied to the intervention group: In the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm. Individuals who did not develop any reaction after thirty minutes and who met other inclusion criteria were included in the study. At the beginning of the study, the patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using 4% massage oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Interventions Applied to the placebo group: In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm. Individuals who did not develop any reaction after 30 minutes and who met other inclusion criteria were included in the study. At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using jojoba fixed oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Interventions Applied to the Control Group: At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. No intervention was applied to individuals in the control group. In order to ensure standardization between the groups, after 15 minutes of verbal communication, they were taken to the EPS process. After the procedure, VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Massage Application: Massage is the stimulation of soft tissues manually or mechanically. It is applied for therapeutic purposes such as maintaining blood and lymph circulation, relaxing muscles, reducing swelling, relieving pain, and providing sleep. The main maneuvers of classical massage are effleurage, petrissage, friction, tapotmen and vibration. In the study, effleurage, petrissage and friction were applied from these maneuvers. 15 to 45 minutes of massage therapy time. It has been reported to vary between. In this study, a 15-minute back massage was applied.
Massage application protocol: 1) The procedure is explained to the individual, his consent is obtained, 2) Hands are washed, gloves are worn, 3) The individual is given a comfortable sitting or lying position, 4) Curtain / screen is drawn or the room door is closed, 5) Back area for massage 6) 3 ml of massage oil is poured into the palms and fingers, 7) A total of 15 minutes of massage is applied by applying five minutes of effleurage, 5 minutes of petrissage, and 5 minutes of friction, 8) Gloves are removed, hands are washed and the process is recorded.
The data were evaluated in the statistical package program of IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA). Descriptive statistics are given as number of units (n), percent (%), mean±standard deviation (x ̅±sd), median (M), first quartile (Q1) and third quartile (Q3). The normal distribution of the data of numerical variables was evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Homogeneity of variances was evaluated with Levene's test. Comparisons between groups for the age variable were made with one-way analysis of variance, and between groups for procedure time and VAS values were made with Kruskal-Wallis analysis. The exact method of the chi-square test was used for the intergroup comparison of categorical variables. Comparison of scale scores between groups according to time was made with two-way analysis of variance in repeated measurements from general linear models. Bonferroni correction was applied to compare the main effects. A p value of <0.05 was accepted for statistical significance.
Ethics committee approval (decision no: 2020/471) from the Erciyes University Clinical Research Ethics Committee and written permission from the unit where the study would be conducted were obtained in order to conduct the study. In addition, those whose written consent was obtained through the Informed Consent Form were included in the study.
- Conditions
- Massage
- Being tested
- aromatherapy massage, classic massage
- Keywords
- Electrophysiological study, Comfort, Back Pain, Massage, Frankincense and Myrrh
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy massageOther
In the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm
classic massageOther
In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group massaged with frankincense and myrrh oil | Experimental | In the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm. Individuals who did not develop any reaction after thirty minutes and who met other inclusion criteria were included in the study. At the beginning of the study, the patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using 4% massage oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. Receives: Other: aromatherapy massage |
| . Placebo group massaged with jojoba oil, | Sham comparator | In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm. Individuals who did not develop any reaction after 30 minutes and who met other inclusion criteria were included in the study. At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using jojoba fixed oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. Receives: Other: classic massage |
| Control group | No intervention | At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. No intervention was applied to individuals in the control group. In order to ensure standardization between the groups, after 15 minutes of verbal communication, they were taken to the EPS process. After the procedure, VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It was used to evaluate the severity of back pain. The patient marks his or her own pain on a 10 cm ruler with painlessness (0) on one end and the most severe pain (10) on the other. The distance between the onset of "no pain" and this point marked by the patient is measured and recorded in centimeters. A high score indicates a high pain intensity.
Measured: four hours
General Comfort Questionary
It was developed by Kolcaba in 1992. It was used to evaluate comfort. The scale is a four-point Likert type, positive and negative contains a total of 48 items. There are four sub-dimensions that physical, psychospiritual, environmental and sociocultural. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is indicated in the 1-4 distribution. Low comfort is expressed by one and high comfort by four.
Measured: four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Oct 2020
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- 1\. Intervention group 2. Placebo group 3. Control group. a randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ülkü özdemir, TC Erciyes University
- Investigators
- ülkü özdemir, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113992
- Sponsor's protocol ID
- 2020/471
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no planing
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Back Massage With Frankincense and Myrrh Oil Before the Cardiac Electrophysiological Procedure on Back Pain Intensity and Comfort
- ClinicalTrials.gov ID
- NCT05113992
- Acronym / sponsor ID
- 2020/471
- Conditions
- Massage
- Keywords
- Electrophysiological study, Comfort, Back Pain, Massage, Frankincense and Myrrh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 9 Nov 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.
This study was conducted to determine the effect of back massage with 4% frankincense and myrrh oil on back pain severity and comfort in patients who will undergo cardiac electrophysiological study (EPS).
Detailed description
The study was conducted as a randomized controlled study. The population of the research consists of individuals who will undergo cardiac EPS in the angio unit of a heart hospital at a university. The sample size was determined as 20 people per group and a total of 60 people for an effect size of 0.131 and a power of 90%. Considering that there may be sample losses, 10 more patients were taken per group, and the study was completed with 30 patients for each group, a total of 90 people.
Randomization: Patients who met the inclusion criteria; They were assigned to one of three groups: 1. Intervention group massaged with frankincense and myrrh oil, 2. Placebo group massaged with jojoba oil, and 3. Control group. In hospital routine, patient appointments for the EPS procedure are determined on a weekly basis. Since the operation day of the research doctor who will perform the EPS procedure is Monday; Since patient rooms are not single occupancy; In addition, groups were randomized computer according to weeks to prevent contamination of frankincense and myrrh oil used for massage in the intervention group to the placebo and control groups.
Data were collected with the Patient Information Form, which includes the sociodemographic and health history of the individuals, the Visual Analogue Scale (VAS) for pain severity assessment, and the General comfort questionary (GCQ) for comfort.
Individuals who met the inclusion criteria in the study were assigned to the 1st Intervention group, 2nd Placebo group, and 3rd Control group in accordance with randomization, with their informed consent. No intervention was made in the standard treatment applied in the clinic.
In a systematic review and meta-analysis study, it is reported that bed rest is recommended for patients at wide intervals from 2 hours to 24 hours (2,4,6,12 and 24 hours) to prevent vascular complications after cardiac catheterization.Therefore, in this study, post-procedure back pain and comfort assessment were checked at the 4th hour, which is the clinical ambulation routine.
Interventions applied to the intervention group: In the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm. Individuals who did not develop any reaction after thirty minutes and who met other inclusion criteria were included in the study. At the beginning of the study, the patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using 4% massage oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Interventions Applied to the placebo group: In the placebo massage group, jojoba fixed oil was applied to the skin on the forearm. Individuals who did not develop any reaction after 30 minutes and who met other inclusion criteria were included in the study. At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using jojoba fixed oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Interventions Applied to the Control Group: At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. No intervention was applied to individuals in the control group. In order to ensure standardization between the groups, after 15 minutes of verbal communication, they were taken to the EPS process. After the procedure, VAS and GCQ were applied again at the 4th hour, which is the ambulation hour.
Massage Application: Massage is the stimulation of soft tissues manually or mechanically. It is applied for therapeutic purposes such as maintaining blood and lymph circulation, relaxing muscles, reducing swelling, relieving pain, and providing sleep. The main maneuvers of classical massage are effleurage, petrissage, friction, tapotmen and vibration. In the study, effleurage, petrissage and friction were applied from these maneuvers. 15 to 45 minutes of massage therapy time. It has been reported to vary between. In this study, a 15-minute back massage was applied.
Massage application protocol: 1) The procedure is explained to the individual, his consent is obtained, 2) Hands are washed, gloves are worn, 3) The individual is given a comfortable sitting or lying position, 4) Curtain / screen is drawn or the room door is closed, 5) Back area for massage 6) 3 ml of massage oil is poured into the palms and fingers, 7) A total of 15 minutes of massage is applied by applying five minutes of effleurage, 5 minutes of petrissage, and 5 minutes of friction, 8) Gloves are removed, hands are washed and the process is recorded.
The data were evaluated in the statistical package program of IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA). Descriptive statistics are given as number of units (n), percent (%), mean±standard deviation (x ̅±sd), median (M), first quartile (Q1) and third quartile (Q3). The normal distribution of the data of numerical variables was evaluated with the Shapiro Wilk test of normality and Q-Q graphs. Homogeneity of variances was evaluated with Levene's test. Comparisons between groups for the age variable were made with one-way analysis of variance, and between groups for procedure time and VAS values were made with Kruskal-Wallis analysis. The exact method of the chi-square test was used for the intergroup comparison of categorical variables. Comparison of scale scores between groups according to time was made with two-way analysis of variance in repeated measurements from general linear models. Bonferroni correction was applied to compare the main effects. A p value of <0.05 was accepted for statistical significance.
Ethics committee approval (decision no: 2020/471) from the Erciyes University Clinical Research Ethics Committee and written permission from the unit where the study would be conducted were obtained in order to conduct the study. In addition, those whose written consent was obtained through the Informed Consent Form were included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1. Intervention group 2. Placebo group 3. Control group. a randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group massaged with frankincense and myrrh oil | Experimental | Other: aromatherapy massageIn the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm. Individuals who did not develop any reaction after thirty minutes and who met other inclusion criteria were included in the study. At the beginning of the study, the patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using 4% massage oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. |
| . Placebo group massaged with jojoba oil, | Sham comparator | Other: classic massageIn the placebo massage group, jojoba fixed oil was applied to the skin on the forearm. Individuals who did not develop any reaction after 30 minutes and who met other inclusion criteria were included in the study. At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. Then, in accordance with the massage application protocol, a back massage was applied for a total of 15 minutes, using jojoba fixed oil. Then EPS was applied to the individuals. VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. |
| Control group | No intervention | –At the beginning of the study, a patient information form, VAS for back pain severity, and GCQ for comfort evaluation were applied by face-to-face interview method before the intervention. No intervention was applied to individuals in the control group. In order to ensure standardization between the groups, after 15 minutes of verbal communication, they were taken to the EPS process. After the procedure, VAS and GCQ were applied again at the 4th hour, which is the ambulation hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who are over 18 years old;
- agreeing to participate in the study;
- EPS planned from the femoral region;
- no communication problems (hearing, vision, speech, perception problems);
- According to VAS, there is no pain in any part of the body before the procedure;
Key exclusion criteria (6 listed)
- Those who had an allergic skin reaction,
- skin disease in the back region,
- a history of fractures or surgical operations in the waist and back region in the last year,
- those who had neurological disorders (hemiparesis, etc.),
- those who received massage therapy in the last three months, those who were diagnosed with cancer,
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 |
|---|---|---|
| aromatherapy massageIn the intervention group, 4% massage oil (3 ml jojoba fixed oil, 2% Frankincense and 2% Myrrh essential oil mixture) was applied on the skin on the forearm | Other | Intervention group massaged with frankincense and myrrh oil |
| classic massageIn the placebo massage group, jojoba fixed oil was applied to the skin on the forearm. | Other | . Placebo group massaged with jojoba oil, |
Primary outcome
Visual Analog Scale
Time frame: four hours
It was used to evaluate the severity of back pain. The patient marks his or her own pain on a 10 cm ruler with painlessness (0) on one end and the most severe pain (10) on the other. The distance between the onset of "no pain" and this point marked by the patient is measured and recorded in centimeters. A high score indicates a high pain intensity.
General Comfort Questionary
Time frame: four hours
It was developed by Kolcaba in 1992. It was used to evaluate comfort. The scale is a four-point Likert type, positive and negative contains a total of 48 items. There are four sub-dimensions that physical, psychospiritual, environmental and sociocultural. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is indicated in the 1-4 distribution. Low comfort is expressed by one and high comfort by four.
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 11 Nov 2021.
- Individual participant dataSharing planned: No. no planing
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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.
ülkü özdemir principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy massage and classic massage in people with Massage, run by TC Erciyes 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 6 inclusion and 6 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 11 Nov 2021. 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?
Visual Analog Scale (time frame: four hours). The study lists 2 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 11 Nov 2021.