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The effect of giving detailed information about intravenous radiopharmaceutical administration on the anxiety level of patients who request more information

Annals of Nuclear Medicine volume 24, pages 67–76 (2010)Cite this article

Abstract

Objectives

Nuclear medicine procedures use radiopharmaceuticals, which produce radiation and potential adverse reactions, albeit at a low rate. It is the patient’s ethical, legal, and medical right to be informed of the potential side effects of procedures applied to them. Our purpose was to determine the effect of providing information about intravenous radiopharmaceutical administration on the anxiety level of patients who request more information.

Materials and methods

This study was completed in two separate Nuclear Medicine Departments. The study included 620 (247 M, 373 F) patients who had been referred for myocardial perfusion, bone, dynamic renal, and thyroid scintigraphic examinations. The patients were divided into two groups according to whether they requested more information or not. Group 1 consisted of 388 patients who wanted to receive more information about the procedure, while Group 2 consisted of 232 patients who did not request additional information. The State-Trait Anxiety Inventory (STAI-S and STAI-T) was used to determine a patient’s anxiety level. After simple information was given, state and trait anxiety levels were measured in both groups. We gave detailed information to the patients in Group 1 and then measured state anxiety again. Detailed information included an explanation of the radiopharmaceutical risk and probable side effects due to the scan procedure.

Results

There was no statistical difference between Groups 1 and 2 in STAI-T or STAI-S scores after simple information was given (p = 0.741 and p = 0.945, respectively). The mean value of STAI-S score was increased after the provision of detailed information and there was a statistically significant difference between after simple information SATI-S and after detailed information STAI-S (p < 0.001). The STAI-S score was increased in 246 patients and decreased in 110 patients after detailed information, while there was no change in 32 patients. After detailed information, the greatest increase in STAI-S score was seen in the myocardial perfusion scan patients, when evaluating according to scan procedure (p < 0.001). However, in the dynamic renal patient group, there was no statistical difference (p = 0.271).

Conclusions

Informed consent including detailed information about radiation exposure, the risk factors, and potential adverse reactions of intravenous radiopharmaceutical administration increased the patients’ anxiety level in those who request more information.

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Author information

Affiliations

  1. Department of Nuclear Medicine, Acibadem Hospital, Melikgazi, Kayseri, Turkey

    Eser Kaya

  2. Department of Nuclear Medicine, Training and Research Hospital, Kayseri, Turkey

    Ismail Ciftci

  3. Department of Public Health, Faculty of Medicine, Afyon Kocatepe University, Afyonkarahisar, Turkey

    Reha Demirel

  4. Afyon Health Training School, Afyon Kocatepe University, Afyonkarahisar, Turkey

    Yeliz Cigerci

  5. Department of Psychiatry, Faculty of Medicine, Afyon Kocatepe University, Afyonkarahisar, Turkey

    Omer Gecici

Authors
  1. Eser Kaya
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  2. Ismail Ciftci
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  3. Reha Demirel
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  4. Yeliz Cigerci
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  5. Omer Gecici
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Corresponding author

Correspondence to Eser Kaya.

Appendix

Appendix

Form 1: Simple informed consent forms

MYOCARDIAL PERFUSION SCAN SIMPLE INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Adverse effects of intravascular radiopharmaceuticals are very rare, and exposure to radiation is very low. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan. The examination will last the entire day and you are required to fast throughout this period. You will be taken to scan twice, post-stress scan and post-rest scan, at 3–4 hour interval.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary in this procedure.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

BONE SCAN SIMPLE INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Adverse effects of intravascular radiopharmaceuticals are very rare, and exposure to radiation is very low. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan. The examination could be in two phases, dynamic and late static phase, and the late static phase examination to last 30–40 minutes will be held about 3–4 hours after the injection. You should drink 1–1,5 L liquids after injection in 30 min. It is not necessary to fast for this study.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary for this procedure.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

DYNAMIC RENAL SCAN SIMPLE INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Adverse effects of intravascular radiopharmaceuticals are very rare, and exposure to radiation is very low. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan.

The scan, which begins simultaneously with radiopharmaceutical injection, will last about 40 min. If found necessary by your physician, the scan could take 15 min longer after the intravenous diuretic injection. Furthermore, you are required to have drunk 500 ml water before the examination, you do not have to fast.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary for this procedure.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

THYROID SCAN SIMPLE INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radioisotope. The isotope is known as non-allergenic, and exposure to radiation is very low. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan.

You are required not to have taken any medicine containing iodine and not to have had any radiologic examination with iodine within one month before the examination. It is not necessary to fast for this procedure.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radioactive material is necessary for this procedure.

I have read and understood the above information, and I accept use of the intravascular radioisotope administration.

Signature

Form 2: Detailed informed consent forms

MYOCARDIAL PERFUSION SCAN DETAILED INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Although safe, there can be some adverse effects; prevalence of adverse reactions for radiopharmaceuticals is estimated to range between 0.3 and 33/105 administrations.

The most probable adverse reactions to cardiac radiopharmaceuticals (Tc99m MIBI) are: nausea, erythema, flushing, diffuse rash, pruritus, seizures, headache, metallic taste and tingling.

Radiation exposure: The radiopharmaceuticals injected for the study produce nearly equal radiation to that used in procedures such as a computerized tomography scan. The radiopharmaceuticals are eliminated from the body through natural decay and waste removal. The total body radiation exposure dose is 8 mSv (millisievert). The main organs exposed to radiation are: the gonads, heart, thyroid, and colon. However, the radiation dose for the general public members is a little more above 5 mSv and this dose is not expected to lead to somatic and/or genetic effects. Accompanying persons and other family members who reside in the same home (pregnant, baby, or child) are exposed to low radiation. If you are pregnant or breast-feeding, or have any disease, this should be declared to your physician prior to the scan. You must fast on the day of the study. Two separate scans will be done, post-stress scan and post-rest scan, at 3–4 hour interval.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary for this procedure. We have the appropriate equipment available in the event of a serious reaction.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

BONE SCAN DETAILED INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Although safe, there can be some adverse effects; prevalence of adverse reactions for radiopharmaceuticals is estimated to range between 0.3 and 33/105 administrations.

The most probable adverse reactions to bone radiopharmaceuticals (Tc99m MDP) are: chills, fever, nausea, vomiting, erythema, flushing, diffuse rash, pruritus, urticaria, cardiac arrest, chest pain, tightness or heaviness, hypertension, hypotension, respiratory reaction, tachycardia, seizures, syncope, dizziness, vertigo, headache, diaphoresis, anaphylaxis, abdominal pain, metallic taste, asthenia, pain/burning at injection site, and photophobia, there has been one death secondary to cardiac arrhythmia.

Radiation exposure: The radiopharmaceuticals injected for the study produce less radiation than in X-ray procedures such as a computerized tomography scan. The radiopharmaceutical is eliminated from the body through natural decay and waste removal. The organs most exposed to radiation are: the bone marrow, bladder, and gonads, the total body radiation exposure dose is 4.5 mSv (millisievert). However, the radiation dose for the general public members is lower than 5 mSv, and this dose is not expected to lead to somatic and/or genetic effects. Accompanying persons and other members of the family who reside in the same home (pregnant, baby, or child), risk exposure to low radiation. If you are pregnant or breast-feeding, or have any disease, this should be declared to your physician prior to the scan.

Your scan may be a two-step, dynamic image at injection time and/or 3–4 hours later, the first step requires 3–5 minutes, and the second procedure requires 30–40 min. You should drink 1–1.5 L of liquids after injection in 30 min. It is not necessary to fast for this study.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary for this procedure. We have the appropriate equipment available in the event of a serious reaction.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

DYNAMIC RENAL SCAN DETAILED INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radiopharmaceuticals. Although safe, may have there can be some adverse effects; prevalence of adverse reactions for radiopharmaceuticals is estimated to range between 0.3 and 33/105 administrations.

The most probable adverse reactions to renal radiopharmaceuticals (Tc99m DTPA) are: chills, nausea, erythema, diffuse rash, pruritus, hives/urticaria, hypertension, hypotension, respiratory reaction, tachycardia, syncope or faintness, headache, cyanosis, anaphylaxis, arthralgia, pain, burning at injection site, cough, and wheezing.

Radiation exposure: The radiopharmaceuticals injected for the study produces less radiation than X-ray procedures such as a computerized tomography scan. The radiopharmaceuticals are eliminated from the body through natural decay and waste removal. The total radiation dose exposure is 3 mSv (millisievert) and the main organs exposed are the bladder and gonads. This amount is not expected to cause any somatic or genetic problems, the radiation dose for the general public members is lower than 5 mSv. Accompanying persons and other members of the family who reside in the same home (pregnant, baby, or child), risk exposure to low radiation. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan.

The scanning will be conducted simultaneously with the radiopharmaceutical injection and will last about 40 min. If necessary, the scanning may take 15 min longer for injecting intravenous diuretic. You are supposed to have ingested 500 ml water and you do not have to fast for this procedure.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radiopharmaceuticals is necessary for this procedure. We have the equipment for use in the event of a serious reaction.

I have read and understood the above information, and I accept use of the intravascular radiopharmaceuticals.

Signature

THYROID SCAN DETAILED INFORMED CONSENT FORM

The aim of this form is to inform you and to obtain your permission to administrate intravascular radioisotope. The isotope is known as non-allergenic. If you are pregnant or breast-feeding, this should be declared to your physician prior to the scan.

You should not have used any thyroid medicine, iodized salt, iodized cough syrup, or iodized tincture and should not have had any iodine radiologic examination. It is not necessary to fast for this study.

After the radioisotope injection, the main organs exposed to radiation are: the thyroid, salivary glands, stomach, and kidneys. The radiation injected will lessen over time passes; during this period, any pregnants, baby or child residing in the same home will be exposed to low radiation. The total radiation dose exposure is 2 mSv (millisievert). However, the radiation dose for the general public members is lower than 5 mSv and this dose is not expected to lead to somatic and/or genetic effects. The exposure amount is lower than that used in a computerized tomography scan.

Your physician has considered these risks before recommending this examination and he/she believes that the diagnostic benefits far outweigh the minimal risks involved. The use of intravascular radioisotope material is necessary for this procedure. We have the appropriate equipment available for use in the event of of a serious reaction.

I have read and understood the above information, and I accept use of the intravascular radioisotope.

Signature

Note: Refs. [7–9, 16–19] are related informed consent forms.

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Kaya, E., Ciftci, I., Demirel, R. et al. The effect of giving detailed information about intravenous radiopharmaceutical administration on the anxiety level of patients who request more information. Ann Nucl Med 24, 67–76 (2010). https://doi.org/10.1007/s12149-009-0329-2

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Keywords

  • Radiopharmaceuticals
  • Detailed information
  • Anxiety level