Critical IllnessEarly Phase 1NCT02423252
Effects of a Psycho-cognitive Nursing Intervention on Patients' Outcomes in Critical Illness
A Early Phase 1 study testing Massage, Relaxation, Guided imagery and music listening. in people with Critical Illness and Stress, run by Dr Elizabeth Papathanassoglou at 1 site in Cyprus.
Trial summary
The purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Stress, Inflammatory Response
- What is being tested?
- Massage, Relaxation, Guided imagery and music listening.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- Mar 2015to May 2016
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Critically ill patients
- Understand Greek language
- Age over 18 years
- They have Richmond Agitation Sedation Scale rate: -3 +3
- Have an Arterial line in place
Who cannot join
- Patient who is expected to stay less than 24 hours in Critical care unit
- Have history of psychiatric disturbances
- Their condition does not permit use of headphones
- Have hearing impairment
- Receive neuro-muscular blockers
- Are confused
- Patients under universal conduct precautions
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Nicosia General Hospital
Nicosia
Maria Hadjibalassi, Phdc
About this study
Official title: The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial
The purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. The investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.
Read the detailed description
In previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. Investigators will examine whether a Psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes.
Sixty ICU patients with or without SIRS will be randomized to receive either standard care or a brief Psycho-cognitive Nursing Intervention, plus standard care, up to 5 days during ICU stay.
- Conditions
- Critical Illness, Stress, Inflammatory Response
- Being tested
- Massage, Relaxation, Guided imagery and music listening., No Intervention
- Keywords
- Critical illness, Intervention, RCT, Relaxation, Guided imagery, Touch/Massage, Music listening, Neuropeptides, Inflammatory molecules, Post-traumatic stress, Critical care nurse, Psychocognitive nursing intervention, Interpersonal support
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage, Relaxation, Guided imagery and music listening.Behavioural
Also called body-mind intervention
In addition to standard care, patients in the intervention group will receive a 60 minutes individually delivered programme, administered once per day by a nurse (the researcher) for up to 5 days during staying in ICU. This session aims to induce relaxation and involves interpersonal support, touch/massage and through a headphone system relaxation and guided imagery exercises and music listening. Patients are provided a CD of the relaxation instructions, after their discharge, for own use
No InterventionOther
Also called standard care, control
The control group will receive the standard care which includes the routine standard care provided by nurses, physiotherapists and intensivists or specialists (e.g. surgeons)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening Receives: Behavioral: Massage, Relaxation, Guided imagery and music listening.; Other: No Intervention |
| Control | No intervention | Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity [10-point numeric rating scale (NRS) scale]
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [Behavioral pain scale (BPS) scale]
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Systolic blood pressure (SBP)
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
Measured: from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Plasma Neuropeptide Y level
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide oxytocin level
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide beta-endorphin level
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide acetylcholine level
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention.
Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Secondary outcomes (21)
Change in Diastolic blood pressure (DAP)
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Mean arterial pressure (MAP)
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Heart rate (HR)
Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Respiration rate (RR)
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Temperature (TMP)
Measured: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Sequential organ failure assessment (SOFA) scores
Measured: once on days 1, 3, 5 and on last day of stay in ICU.
Multiple organ disfunction syndrome (MODS) scores
Measured: once on days 1, 3, 5 and on last day of stay in ICU.
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Measured: morning before starting intervention (days 1-5)
Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported fear level [10-point numeric rating scale (NRS)
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported optimism level [10-point numeric rating scale (NRS)
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported distress level [10-point numeric rating scale (NRS)]
Measured: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Richmond agitation-sedation scale (RASS) score
Measured: days 1, 2, 3, 4, 5.
Change in Plasma levels of Inflammatory marker Interleukin-6
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker Interleukin-8
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)]
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention.
Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
Measured: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).
Measured: within 48 hours post discharge from ICU
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
Measured: one month and six months after hospital discharge
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Measured: one month and six months after discharge
Exploration of lived experience of critical illness (phenomenological interviews)
Measured: one month and six months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Elizabeth Papathanassoglou
- Sponsor type
- University, hospital or other
- Collaborators
- Nicosia General Hospital
- Responsible party
- Sponsor-investigator, Dr Elizabeth Papathanassoglou, Cyprus University of Technology
- Investigators
- Elizabeth DE Papathanassoglou, Phd, Study director, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423252
- Sponsor's protocol ID
- EX 043 - EP1
- Other IDs
- EX 043 EPPSY-13
- Status last verified
- Apr 2015
- First submitted
- 28 Mar 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02423252
- Acronym / sponsor ID
- EX 043 - EP1
- Conditions
- Critical Illness, Stress, Inflammatory Response
- Keywords
- Critical illness, Intervention, RCT, Relaxation, Guided imagery, Touch/Massage, Music listening, Neuropeptides
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr Elizabeth PapathanassoglouUniversity, hospital or other
- Collaborators
- Nicosia General Hospital
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 22 Apr 2015 (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 investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. The investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.
Detailed description
In previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. Investigators will examine whether a Psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes.
Sixty ICU patients with or without SIRS will be randomized to receive either standard care or a brief Psycho-cognitive Nursing Intervention, plus standard care, up to 5 days during ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Massage, Relaxation, Guided imagery and music listening., Other: No InterventionIntervention: Massage, Relaxation, imagery, music. Patients in Intervention group will receive standard care plus massage, relaxation, guided imagery and music listening |
| Control | No intervention | –Patients in control group will receive standard care only. Same records and outcome measures with intervention group will apply for control group as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Critically ill patients
- Understand Greek language
- Age over 18 years
- They have Richmond Agitation Sedation Scale rate: -3 +3
- Have an Arterial line in place
Key exclusion criteria (7 listed)
- Patient who is expected to stay less than 24 hours in Critical care unit
- Have history of psychiatric disturbances
- Their condition does not permit use of headphones
- Have hearing impairment
- Receive neuro-muscular blockers
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 |
|---|---|---|
| Massage, Relaxation, Guided imagery and music listening.Also: body-mind interventionIn addition to standard care, patients in the intervention group will receive a 60 minutes individually delivered programme, administered once per day by a nurse (the researcher) for up to 5 days during staying in ICU. This session aims to induce relaxation and involves interpersonal support, touch/massage and through a headphone system relaxation and guided imagery exercises and music listening. Patients are provided a CD of the relaxation instructions, after their discharge, for own use | Behavioural | Intervention group |
| No InterventionAlso: standard care, controlThe control group will receive the standard care which includes the routine standard care provided by nurses, physiotherapists and intensivists or specialists (e.g. surgeons) | Other | Intervention group |
Primary outcome
Change in Pain intensity [10-point numeric rating scale (NRS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [Behavioral pain scale (BPS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Systolic blood pressure (SBP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
Time frame: from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Plasma Neuropeptide Y level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide oxytocin level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide beta-endorphin level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide acetylcholine level
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention. Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
21 secondary outcomes
Change in Diastolic blood pressure (DAP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Mean arterial pressure (MAP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Heart rate (HR)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Respiration rate (RR)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Change in Temperature (TMP)
Time frame: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),
Sequential organ failure assessment (SOFA) scores
Time frame: once on days 1, 3, 5 and on last day of stay in ICU.
Multiple organ disfunction syndrome (MODS) scores
Time frame: once on days 1, 3, 5 and on last day of stay in ICU.
Self reported quality of Sleep [10-point numeric rating scale (NRS) scale]
Time frame: morning before starting intervention (days 1-5)
Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported fear level [10-point numeric rating scale (NRS)
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported optimism level [10-point numeric rating scale (NRS)
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Self reported distress level [10-point numeric rating scale (NRS)]
Time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Richmond agitation-sedation scale (RASS) score
Time frame: days 1, 2, 3, 4, 5.
Change in Plasma levels of Inflammatory marker Interleukin-6
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker Interleukin-8
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)]
Time frame: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).
Time frame: within 48 hours post discharge from ICU
Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)
Time frame: one month and six months after hospital discharge
assessment of quality of life using Short Form 36 version2 scale (SF36v2)
Time frame: one month and six months after discharge
Exploration of lived experience of critical illness (phenomenological interviews)
Time frame: one month and six months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
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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.
Elizabeth DE Papathanassoglou, Phd study director
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 Early Phase 1 study testing Massage, Relaxation, Guided imagery and music listening. in people with Critical Illness and Stress, run by Dr Elizabeth Papathanassoglou 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 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: status not confirmed, as of the sponsor's last update on 22 Apr 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Hadjibalassi, Phdc (0035799355610, maria.hadjibalassi@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity [10-point numeric rating scale (NRS) scale] (time frame: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).). The study lists 9 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 22 Apr 2015.