Motivational InterviewingNCT06424574
The Effect of Motivational Interviewing in Children With Type 1 Diabetes
A study testing motivational interview in people with Motivational Interviewing and Type 1 Diabetes, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, Type 1 Diabetes, Hypoglycemia
- What is being tested?
- motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2021to 19 Aug 2022
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- with a child diagnosed with T1D between the ages of 2-18 years,
- Can read and write Turkish, can be reached and communicated with,
- Orientation and co-operation,
- Without hearing, understanding and vision problems,
- Parents who agreed to participate in the study
Who cannot join
- Communication difficulties,
- It is determined as being illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Motivational Interviewing on Hypoglycemia Fear Caring Failure and Self-commission in Parents of Children With Type 1 Diabetes
This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
Read the detailed description
This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
- Being tested
- motivational interview
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewBehavioural
Also called Experimental
The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used. The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the xvii interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | I. Interview: -Research for parents information was given about. Pretest forms were applied.
Pre-test forms from filling;
1. st interview after 2 weeks (45 min)
2. nd interview after 2 weeks (45 min)
3. Interviews after 2 weeks (45 min)
4. th interview after 2 weeks (45 min)
5. th interview: Post-test data were obtained 2 weeks after the last interview they were. Receives: Behavioral: motivational interview |
| Standard care | No intervention | I. Interview: -Research for parents information was given about. Pretest forms were applied. II interview: Post-test data were obtained 2 weeks after the last interview they were. Post-test data were obtained 10 weeks after the last interview (it was ensured that the same time period passed with the experimental group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp)
University of Virginia Parental Fear of Low Blood Sugar Scale (P-LBSS)" It was developed by Gonder-Frederick and colleagues to assess parents' fear of their children's HG . The scale is a 4-point Likert-type scale consisting of 25 questions and two subscales (behavior, anxiety). Scoring on the scale is between 0 and 100, and the higher the score obtained from the scale, the higher the rate of HG fear increase. The Cronbach alpha reliability coefficients of the original scale were found to be 0.89, 0.76, and 0.91 for the total scale, behavior subscale, and anxiety subscale, respectively.
Measured: 13 monts
The effect of motivational interviewing on parents' caregiving effects
"Bakas Caregiving Impact Scale" is a measurement tool developed by Bakas and colleagues in 1999 to evaluate how the experiences of caregivers change with the caregiving process.The scale consists of a total of 15 items and shows positive and negative effects. The scale is a Likert-type scale, scored from +3 (in the best direction) to -3 (in the worst direction), ranging from 1 to 7. Scoring is done as -3=1, -2=2, -1=3, 0=4, +1=5, +2=6, +3=7. The lowest score that can be obtained from the scale is 15; the highest score is 10. As the scores increase, they are interpreted as ''change in the good direction'', and as the scores decrease, they are interpreted as ''change in the bad direction''. The internal consistency number of the original scale was found as 0.90, and the test-retest reliability was found as 0.81.
Measured: 13 months
The effect of motivational interviewing on parents' fatigue severity
The Fatigue Severity Scale, which was also developed in the USA, was used for the first time in patients with multiple sclerosis. was used. Turkish validity and reliability study of the scale. It was conducted by Armutlu et al. in 2007. The scale has 9 questions and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. The scale determines the fatigue status of individuals in the last 1 month. The questions are scored as strongly disagree (1)- strongly agree (7). The scale score is the average value of the questions. If the average score is 4 and above, it is considered as "severe fatigue". The lower the total score, the less "fatigue".
Measured: 13 months
The effect of motivational interviewing on parents' level of self-compassion
The scale was developed by Tanenbaum et al. in 2020 to measure whether they have self-efficacy in coping with diabetes and coping with their emotions. The scale consists of 19 items and is a 5-point Likert-type scale (1="Almost never" and 5="Almost always"). Scale Positive dimension It has a two-factor structure as negative and negative dimension. The total score is calculated by averaging all items. Higher scores indicate higher diabetes-specific self-compassion
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start26 Jul 2021
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Çiftci Baykal, Yuzuncu Yil University
- Investigators
- Dilek ÇİFTCİ BAYKA, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424574
- Sponsor's protocol ID
- DBAYKAL1421
- Status last verified
- Jul 2024
- First submitted
- 16 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50.
PubMed 20633252Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.
PubMed 12876161Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
PubMed 17351283
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Hypoglycemia Fear Caring Failure and Self-commission in Parents of Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06424574
- Acronym / sponsor ID
- DBAYKAL1421
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 22 May 2024 (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 research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
Detailed description
This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: motivational interviewI. Interview: -Research for parents information was given about. Pretest forms were applied. Pre-test forms from filling; 1. st interview after 2 weeks (45 min) 2. nd interview after 2 weeks (45 min) 3. Interviews after 2 weeks (45 min) 4. th interview after 2 weeks (45 min) 5. th interview: Post-test data were obtained 2 weeks after the last interview they were. |
| Standard care | No intervention | –I. Interview: -Research for parents information was given about. Pretest forms were applied. II interview: Post-test data were obtained 2 weeks after the last interview they were. Post-test data were obtained 10 weeks after the last interview (it was ensured that the same time period passed with the experimental group) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- with a child diagnosed with T1D between the ages of 2-18 years,
- Can read and write Turkish, can be reached and communicated with,
- Orientation and co-operation,
- Without hearing, understanding and vision problems,
- Parents who agreed to participate in the study
Key exclusion criteria (2 listed)
- Communication difficulties,
- It is determined as being illiterate.
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 |
|---|---|---|
| motivational interviewAlso: ExperimentalThe sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used. The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the xvii interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion. | Behavioural | Motivational interviewing |
Primary outcome
The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp)
Time frame: 13 monts
University of Virginia Parental Fear of Low Blood Sugar Scale (P-LBSS)" It was developed by Gonder-Frederick and colleagues to assess parents' fear of their children's HG . The scale is a 4-point Likert-type scale consisting of 25 questions and two subscales (behavior, anxiety). Scoring on the scale is between 0 and 100, and the higher the score obtained from the scale, the higher the rate of HG fear increase. The Cronbach alpha reliability coefficients of the original scale were found to be 0.89, 0.76, and 0.91 for the total scale, behavior subscale, and anxiety subscale, respectively.
The effect of motivational interviewing on parents' caregiving effects
Time frame: 13 months
"Bakas Caregiving Impact Scale" is a measurement tool developed by Bakas and colleagues in 1999 to evaluate how the experiences of caregivers change with the caregiving process.The scale consists of a total of 15 items and shows positive and negative effects. The scale is a Likert-type scale, scored from +3 (in the best direction) to -3 (in the worst direction), ranging from 1 to 7. Scoring is done as -3=1, -2=2, -1=3, 0=4, +1=5, +2=6, +3=7. The lowest score that can be obtained from the scale is 15; the highest score is 10. As the scores increase, they are interpreted as ''change in the good direction'', and as the scores decrease, they are interpreted as ''change in the bad direction''. The internal consistency number of the original scale was found as 0.90, and the test-retest reliability was found as 0.81.
The effect of motivational interviewing on parents' fatigue severity
Time frame: 13 months
The Fatigue Severity Scale, which was also developed in the USA, was used for the first time in patients with multiple sclerosis. was used. Turkish validity and reliability study of the scale. It was conducted by Armutlu et al. in 2007. The scale has 9 questions and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. The scale determines the fatigue status of individuals in the last 1 month. The questions are scored as strongly disagree (1)- strongly agree (7). The scale score is the average value of the questions. If the average score is 4 and above, it is considered as "severe fatigue". The lower the total score, the less "fatigue".
The effect of motivational interviewing on parents' level of self-compassion
Time frame: 13 months
The scale was developed by Tanenbaum et al. in 2020 to measure whether they have self-efficacy in coping with diabetes and coping with their emotions. The scale consists of 19 items and is a 5-point Likert-type scale (1="Almost never" and 5="Almost always"). Scale Positive dimension It has a two-factor structure as negative and negative dimension. The total score is calculated by averaging all items. Higher scores indicate higher diabetes-specific self-compassion
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 3 Jul 2024.
- Background: PubMed 20633252Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50.
- Background: PubMed 12876161Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.
- Background: PubMed 17351283Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
- Individual participant dataSharing planned: No
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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.
Dilek ÇİFTCİ BAYKA study director
Yuzuncu Yil 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 motivational interview in people with Motivational Interviewing and Type 1 Diabetes, run by Yuzuncu Yil 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 5 inclusion and 2 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 3 Jul 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?
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?
The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp) (time frame: 13 monts). 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?
On the ClinicalTrials.gov record for NCT06424574, which also lists 3 linked publications.
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 3 Jul 2024.