AnxietyNCT03985267
A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer
A study testing Mindfulness based Swinging Effect Intervention in people with Anxiety and Stress, run by University of Barcelona at 2 sites in Turkey (Türkiye).
Trial summary
It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Stress, Self Efficacy
- What is being tested?
- Mindfulness based Swinging Effect Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 29 Nov 2018to 20 Oct 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 and over who can consent
- Only women participants
- Diagnosed with breast cancer
- Native Turkish speaker
- Currently under cancer treatment (not in remission)
- Score at least 10 points for Hospital and Depression Scale (5 for anxiety, 5 for depression)
Show all 9Show fewer
- Score at least 6 points for Self-Efficacy for Managing Chronic Disease (in overall)
- Score at least 2 points for the Beck's Hopelessness Scale (in overall)
- Score at least 20 points for State Trait Anxiety Inventory.
Who cannot join
- Being illiterate
- Having any type of psychiatric history
- Currently being on psychiatric/neurological medication
- Having mental retardation
- Having a fear of swings/swinging
- Having a severe respiratory illness/severe difficulty in breathing
- Suffering from any asthmatic or epileptic illnesses
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
EgeMed Hospital
Aydin, Soke
Ozel Oz Psikoloji Aile Danisma Merkezi (Oz Psychology Family Counselling Centre)
Izmir, Konak
About this study
Official title: Efficacy of Mindfulness Based Swinging Technique (MBST) for Improving Anxiety, Stress, Hopelessness and Self Efficacy Among Breast Cancer Patients in Treatment
It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. This intervention intended to support patients' management of their chronic illness (self-efficacy) by increasing their hope about their treatment and alleviate anxiety, as well as increase patient saturation level. Therefore, enabling patients to continue to their medical as well as psychological treatment will result improved anxiety, stress levels, hope and self-efficacy. It is known that mental health needs of cancer patients differ from people who do not suffer from a chronic illness.
Read the detailed description
Participation in this research is entirely voluntary. Participants are required to complete a semi-screening assessment form which asks socio-demographic and bio-medical information. This form is also assess participants eligibility to take part. Then will ask participants to complete the Hospital and Depression Scale (HADS), Self-Efficacy for Managing Chronic Disease (SEMCD), Beck's Hopelessness Scale (BHS), Emotion Thermometer (ET), State Trait Anxiety Inventory (STAI) before and after (pre-post) their allocated intervention (arm). Participants have the right to answer as many or as few questions asked as they wish. They also have the right to withdraw from the study up to four weeks after they have completed the required psychometric measurement tools. Should they wish to withdraw then they will need to inform the researcher by email, quoting their unique participation identification code which will be generated before beginning the study using their name initials and date of birth. This will enable researcher to identify all the materials that needs to be deleted due to their withdrawal from the project. Alternatively, if they decide that they no longer want to take part in the study they can notify the researcher/clinician immediately and their recorded information (if any) will be completely erased from the study. Other than answering a number of demographic questions (in order to establish the characteristics of the sample), participants will not be directly disclosing any confidential personal information. However, the survey completion data will be checked for any identifying information and anonymised if necessary. Participants will be allocated a code number, and this will be used when quoting from the data-set. The data will be kept confidential and stored in a safe locked cabinet/storage at all times. The ethical approval is obtained from one of the Turkish institution where they issue ethical approval in accordance with the ethical standards of the Helsinki declaration.
- Conditions
- Anxiety, Stress, Self Efficacy, Depression, Breast Cancer Female, Hopefulness
- Being tested
- Mindfulness based Swinging Effect Intervention
- Keywords
- mindfulness, breast cancer, psycho-oncology, clinical health psychology, ontology, swinging effect intervention, breathing technique, guided imagery, cognitive behavioural therapy
- Medical subject headings
- Anxiety Disorders, Depression, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based Swinging Effect InterventionBehavioural
Also called Breathing Technique, Guided Imagery Technique, Cognitive Behavioural Therapy (CBT), Mindfulness
Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Swinging Technique (MBST) | Experimental | Standard guided imagery combined with Mindfulness and breathing technique will be applied. Additionally, the directives will be given to participants to imagine themselves swinging in a green peaceful environment where they will face no harm but healing and full of wellness. Every time they imagine their swing goes up, patient will be asked to physically take a deep breath (taking the breath will be physically (actually) done, not imagining), and when going down patient will be asked to physically release their breath (releasing breath will be physically (actually) done, not imagining). Receives: Behavioral: Mindfulness based Swinging Effect Intervention |
| Standard Treatment | Active comparator | Participants will receive a session of standard psycho-social care for anxiety (50 minutes length). The standard psycho-social care interventions involve the most well-known talking therapy approach of Cognitive Behavioural Therapy (CBT). Receives: Behavioral: Mindfulness based Swinging Effect Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to reduce stress and anxiety for breast cancer patients. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.
Measured: 20minutes
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used right before and after the intervention. If two consecutive numbers are circled, the lower number will be coded (less self-efficacy). The score for the scale is the mean of the six items. If more than two items will be missing, scoring the scale will not happen. Higher number indicates higher self-efficacy.The higher values represent a better outcome for this scale.
Measured: 20 minutes
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used right before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.
Measured: 20 minutes
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used before and after the intervention. Each of the 6 items are rated from 1 (not at all confident) to 10 (totally confident). The overall score is derived from the mean of the 6 items. The total minimum score will be 6 (very low self-efficacy), and maximum total score will be 60 (very high self-efficacy). Higher scores indicate a better self-efficacy.
Measured: 8 weeks
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.
Measured: 8 weeks
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the State Trait Anxiety Inventory.
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety State Trait Anxiety Inventory will be used before and after the intervention. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.
Measured: 8 weeks
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using Emotion Thermometer.
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Emotion Thermometer will be used before and after the intervention. To calculate the Emotion Thermometer the fixed cut-offs will be used meaning that 0-3 (low) and 4-10 (high) on each component.
Measured: 8 weeks
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the Hospital Anxiety and Depression Scale.
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Hospital Anxiety and Depression Scale will be used before and after the intervention. To calculate Hospital Anxiety and Depression Scale the cut of scores are 0-7 considered in normal range, 8-10 considered in Borderline abnormal (borderline case) and 11-21 considered in Abnormal (case) respectively.
Measured: 8 weeks
Secondary outcomes (5)
Impact of education level on efficacy of the Mindfulness Based Swinging Technique (MBST)
To observe whether breast cancer patients' education level has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce anxiety and increase self-efficacy and hopefulness. The participants' education level will be obtained from self-reported socio-demographic semi-screening assessment form.
Measured: 20 minutes to 8 weeks
Impact of marital status on efficacy of the Mindfulness Based Swinging Technique (MBST)
To observe whether breast cancer patients' marital status has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST). The participants' marital status will be obtained from self-reported socio-demographic semi-screening assessment form.
Measured: 20 minutes to 8 weeks
Impact of living arrangements on efficacy of the Mindfulness Based Swinging Technique (MBST)
To observe whether breast cancer patients' living arrangement has any impact on efficacy of the Mindfulness Based Swinging Technique (MBST). The participants' living arrangement status will be obtained from self-reported socio-demographic semi-screening assessment form.
Measured: 20 minutes to 8 weeks
Impact of time for learning cancer diagnosis on efficacy of the Mindfulness Based Swinging Technique (MBST)
To observe whether breast cancer patients' time for learning their cancer diagnosis has any impact on efficacy of Mindfulness Based Swinging Technique (MBST). The information of when participants have learnt their cancer diagnosis will be obtained from self-reported socio-demographic semi-screening assessment form.
Measured: 20 minutes to 8 weeks
Impact of having any metastasis on efficacy of the Mindfulness Based Swinging Technique (MBST)
To observe whether breast cancer patients' metastatic status has any impact on efficacy of Mindfulness Based Swinging Technique (MBST). The participants' metastatic status will be obtained from self-reported socio-demographic semi-screening assessment form.
Measured: 20 minutes to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start29 Nov 2018
- Primary completion1 Aug 2021
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan BAHCIVAN, University of Barcelona
- Investigators
- Jose M Maldonado, PhD, MSc, Study director, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985267
- Sponsor's protocol ID
- 2018/14-01
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data results and outcome will be available to researchers once it is published on a journal.
Publications
Bahcivan O, Estape T, Gutierrez-Maldonado J. The swinging effect intervention: CBT based guided imagery and breathing technique integrated with mindfulness therapy for cancer patients. Med Hypotheses. 2018 Dec;121:42-43. doi: 10.1016/j.mehy.2018.09.007. Epub 2018 Sep 6. No abstract available.
PubMed 30396486Bahcivan O, Estape T, Gutierrez-Maldonado J. Efficacy of New Mindfulness-Based Swinging Technique Intervention: A Pilot Randomised Controlled Trial Among Women With Breast Cancer. Front Psychol. 2022 Jul 4;13:863857. doi: 10.3389/fpsyg.2022.863857. eCollection 2022.
PubMed 35859820
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness Based Swinging Technique (MBST) for Improving Anxiety, Stress, Hopelessness and Self Efficacy Among Breast Cancer Patients in Treatment
- ClinicalTrials.gov ID
- NCT03985267
- Acronym / sponsor ID
- 2018/14-01
- Conditions
- Anxiety, Stress, Self Efficacy, Depression, Breast Cancer Female, Hopefulness
- Keywords
- mindfulness, breast cancer, psycho-oncology, clinical health psychology, ontology, swinging effect intervention, breathing technique, guided imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 13 Jun 2019 (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.
It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. This intervention intended to support patients' management of their chronic illness (self-efficacy) by increasing their hope about their treatment and alleviate anxiety, as well as increase patient saturation level. Therefore, enabling patients to continue to their medical as well as psychological treatment will result improved anxiety, stress levels, hope and self-efficacy. It is known that mental health needs of cancer patients differ from people who do not suffer from a chronic illness.
Detailed description
Participation in this research is entirely voluntary. Participants are required to complete a semi-screening assessment form which asks socio-demographic and bio-medical information. This form is also assess participants eligibility to take part. Then will ask participants to complete the Hospital and Depression Scale (HADS), Self-Efficacy for Managing Chronic Disease (SEMCD), Beck's Hopelessness Scale (BHS), Emotion Thermometer (ET), State Trait Anxiety Inventory (STAI) before and after (pre-post) their allocated intervention (arm). Participants have the right to answer as many or as few questions asked as they wish. They also have the right to withdraw from the study up to four weeks after they have completed the required psychometric measurement tools. Should they wish to withdraw then they will need to inform the researcher by email, quoting their unique participation identification code which will be generated before beginning the study using their name initials and date of birth. This will enable researcher to identify all the materials that needs to be deleted due to their withdrawal from the project. Alternatively, if they decide that they no longer want to take part in the study they can notify the researcher/clinician immediately and their recorded information (if any) will be completely erased from the study. Other than answering a number of demographic questions (in order to establish the characteristics of the sample), participants will not be directly disclosing any confidential personal information. However, the survey completion data will be checked for any identifying information and anonymised if necessary. Participants will be allocated a code number, and this will be used when quoting from the data-set. The data will be kept confidential and stored in a safe locked cabinet/storage at all times. The ethical approval is obtained from one of the Turkish institution where they issue ethical approval in accordance with the ethical standards of the Helsinki declaration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Swinging Technique (MBST) | Experimental | Behavioral: Mindfulness based Swinging Effect InterventionStandard guided imagery combined with Mindfulness and breathing technique will be applied. Additionally, the directives will be given to participants to imagine themselves swinging in a green peaceful environment where they will face no harm but healing and full of wellness. Every time they imagine their swing goes up, patient will be asked to physically take a deep breath (taking the breath will be physically (actually) done, not imagining), and when going down patient will be asked to physically release their breath (releasing breath will be physically (actually) done, not imagining). |
| Standard Treatment | Active comparator | Behavioral: Mindfulness based Swinging Effect InterventionParticipants will receive a session of standard psycho-social care for anxiety (50 minutes length). The standard psycho-social care interventions involve the most well-known talking therapy approach of Cognitive Behavioural Therapy (CBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18 and over who can consent
- Only women participants
- Diagnosed with breast cancer
- Native Turkish speaker
- Currently under cancer treatment (not in remission)
Key exclusion criteria (7 listed)
- Being illiterate
- Having any type of psychiatric history
- Currently being on psychiatric/neurological medication
- Having mental retardation
- Having a fear of swings/swinging
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 |
|---|---|---|
| Mindfulness based Swinging Effect InterventionAlso: Breathing Technique, Guided Imagery Technique, Cognitive Behavioural Therapy (CBT), MindfulnessParticipants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively. | Behavioural | Mindfulness Based Swinging Technique (MBST), Standard Treatment |
Primary outcome
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety
Time frame: 20minutes
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to reduce stress and anxiety for breast cancer patients. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
Time frame: 20 minutes
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used right before and after the intervention. If two consecutive numbers are circled, the lower number will be coded (less self-efficacy). The score for the scale is the mean of the six items. If more than two items will be missing, scoring the scale will not happen. Higher number indicates higher self-efficacy.The higher values represent a better outcome for this scale.
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
Time frame: 20 minutes
To assess the immediate outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used right before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
Time frame: 8 weeks
To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used before and after the intervention. Each of the 6 items are rated from 1 (not at all confident) to 10 (totally confident). The overall score is derived from the mean of the 6 items. The total minimum score will be 6 (very low self-efficacy), and maximum total score will be 60 (very high self-efficacy). Higher scores indicate a better self-efficacy.
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
Time frame: 8 weeks
To assess the long term follow up outcome of the Mindfulness Based Swinging Technique (MBST) whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the State Trait Anxiety Inventory.
Time frame: 8 weeks
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety State Trait Anxiety Inventory will be used before and after the intervention. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using Emotion Thermometer.
Time frame: 8 weeks
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Emotion Thermometer will be used before and after the intervention. To calculate the Emotion Thermometer the fixed cut-offs will be used meaning that 0-3 (low) and 4-10 (high) on each component.
Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the Hospital Anxiety and Depression Scale.
Time frame: 8 weeks
To assess the long term follow up of the Mindfulness Based Swinging Technique (MBST) for reducing stress and anxiety Hospital Anxiety and Depression Scale will be used before and after the intervention. To calculate Hospital Anxiety and Depression Scale the cut of scores are 0-7 considered in normal range, 8-10 considered in Borderline abnormal (borderline case) and 11-21 considered in Abnormal (case) respectively.
5 secondary outcomes
Impact of education level on efficacy of the Mindfulness Based Swinging Technique (MBST)
Time frame: 20 minutes to 8 weeks
Impact of marital status on efficacy of the Mindfulness Based Swinging Technique (MBST)
Time frame: 20 minutes to 8 weeks
Impact of living arrangements on efficacy of the Mindfulness Based Swinging Technique (MBST)
Time frame: 20 minutes to 8 weeks
Impact of time for learning cancer diagnosis on efficacy of the Mindfulness Based Swinging Technique (MBST)
Time frame: 20 minutes to 8 weeks
Impact of having any metastasis on efficacy of the Mindfulness Based Swinging Technique (MBST)
Time frame: 20 minutes to 8 weeks
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 Nov 2022.
- Background: PubMed 30396486Bahcivan O, Estape T, Gutierrez-Maldonado J. The swinging effect intervention: CBT based guided imagery and breathing technique integrated with mindfulness therapy for cancer patients. Med Hypotheses. 2018 Dec;121:42-43. doi: 10.1016/j.mehy.2018.09.007. Epub 2018 Sep 6. No abstract available.
- Results publication: PubMed 35859820Bahcivan O, Estape T, Gutierrez-Maldonado J. Efficacy of New Mindfulness-Based Swinging Technique Intervention: A Pilot Randomised Controlled Trial Among Women With Breast Cancer. Front Psychol. 2022 Jul 4;13:863857. doi: 10.3389/fpsyg.2022.863857. eCollection 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. data results and outcome will be available to researchers once it is published on a journal.
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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.
Jose M Maldonado, PhD, MSc study director
University of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based Swinging Effect Intervention in people with Anxiety and Stress, run by University of Barcelona at 2 sites 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 9 inclusion and 7 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 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety (time frame: 20minutes). The study lists 8 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 NCT03985267, which also lists 2 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 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.