AnxietyNCT01590524
Feasibility Study on the Effect of Complementary Methods as Supportive Interventions for Parents of Children With Cancer
A study testing Guided Imagery and Progressive Muscle Relaxation in people with Anxiety and Stress, run by Cyprus University of Technology at 1 site in Cyprus.
Trial summary
The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Guided Imagery and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCyprus
- Study dates
- Apr 2012to Oct 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- willingness to participate
- having a child with childhood cancer been hospitalized for 4 weeks
- have a child (0-18) of age with childhood cancer
- able to speak and write Greek fluently
- no previous experience with CAM techniques
Who cannot join
- receiving drug therapy for stress
- using another CAM technique during the study
- parents of children receiving palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer
The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.
Read the detailed description
Having a children with cancer can be a source of stress for parents during hospitalization. The stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. The studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. Since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents.
- Being tested
- Guided Imagery and Progressive Muscle Relaxation
- Keywords
- Parent, childhood cancer, Complementary and Alternative
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery and Progressive Muscle RelaxationBehavioural
Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
| Study group | Role | What they receive |
|---|---|---|
| CAM group | Experimental | Subjects receiving the interventions and standard psychological care Receives: Behavioral: Guided Imagery and Progressive Muscle Relaxation |
| No-CAM group | No intervention | Parents receiving only standard psychological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of Participants with anxiety
Participants response to the complementary and alternative intervention will be measured through their scores on the Hamilton Anxiety Scale
Measured: 1 week, 2 week, 3 week , 4 week
Secondary outcomes (2)
Changes in the number of Participants with mood changes
Participants response to the complementary and alternative interventions will be measured through their scores on the POMS scale
Measured: 1 week, 2 week, 3 week , 4 week
stress level with Biodots
Measured: 1 week, 2 week, 3 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionOct 2014
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.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas Charalambous, PhD, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590524
- Sponsor's protocol ID
- AC-GIPMRL-87
- Status last verified
- Oct 2014
- First submitted
- 8 Feb 2012
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for the Effect of Guided Imagery and Progressive Muscle Relaxation in Reducing Anxiety for Parents of Hospitalized Children With Cancer
- ClinicalTrials.gov ID
- NCT01590524
- Acronym / sponsor ID
- AC-GIPMRL-87
- Keywords
- Parent, childhood cancer, Complementary and Alternative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- 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.
The purpose of this study is to determine whether Guided Imagery and Progressive Muscle relaxation are effective as stress reducing techniques in parents of hospitalized children with cancer.
Detailed description
Having a children with cancer can be a source of stress for parents during hospitalization. The stress experienced by the parents can negatively influence their functionality, daily activities, psychological state and also their physical condition. The studies in the literature have mainly focused on the child rather than the parent, and studies specifically for guided imagery are scarce. Since the parents are often neglected by the healthcare professionals during the stress evoking period of hospitalization, this study will test the effectiveness of complementary methods in improving the psychological state of the parents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM group | Experimental | Behavioral: Guided Imagery and Progressive Muscle RelaxationSubjects receiving the interventions and standard psychological care |
| No-CAM group | No intervention | –Parents receiving only standard psychological care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- willingness to participate
- having a child with childhood cancer been hospitalized for 4 weeks
- have a child (0-18) of age with childhood cancer
- able to speak and write Greek fluently
- no previous experience with CAM techniques
Key exclusion criteria (3 listed)
- receiving drug therapy for stress
- using another CAM technique during the study
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 |
|---|---|---|
| Guided Imagery and Progressive Muscle RelaxationDaily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions. | Behavioural | CAM group |
Primary outcome
Changes in the number of Participants with anxiety
Time frame: 1 week, 2 week, 3 week , 4 week
Participants response to the complementary and alternative intervention will be measured through their scores on the Hamilton Anxiety Scale
2 secondary outcomes
Changes in the number of Participants with mood changes
Time frame: 1 week, 2 week, 3 week , 4 week
stress level with Biodots
Time frame: 1 week, 2 week, 3 week, 4 week
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 8 Oct 2014.
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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.
Andreas Charalambous, PhD principal investigator
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Progressive Muscle Relaxation in people with Anxiety and Stress, run by Cyprus University of Technology at 1 site in Cyprus.
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 3 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 8 Oct 2014. 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 Cyprus. 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?
Changes in the number of Participants with anxiety (time frame: 1 week, 2 week, 3 week , 4 week). 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 8 Oct 2014.